Paul Pirtea, Dominique de Ziegler, James Toner, Richard Scott, Jean-Marc Ayoubi
We read with interest the article by Melo et al. regarding progesterone levels and ART outcomes in all regimens used for priming frozen embryo transfers (FET) (Melo et al., 2022). This article follows a slew of publications on the topic and a metaanalysis conducted by these very authors (Melo et al., 2021). According to the mustered studies, lower serum progesterone levels on, or near, the day of embryo transfer (ET) in women receiving vaginal progesterone are associated with poorer FET outcomes (Melo et al., 2021). The present article by Melo et al. is new in that it studies the links between serum progesterone levels and the outcomes in all forms of treatment used for priming FET (Melo et al., 2022). This also includes the situation when subcutaneous progesterone (LubionR ) 25 mg BID is used exclusively (Melo et al., 2022). In this particular case, the study shows a biphasic relationship between serum progesterone levels and FET outcome with a sharp decrease in outcome when serum progesterone exceeds 16.3 ng/ml on the day of ET (Melo et al., 2022). Based on their observation, the authors suggest that serum levels of progesterone that exceed this mark exert a counterproductive effect on embryo implantation. Aside from the weaknesses of their study—for instance, there is no indication as to why patients were prescribed HRT using exclusively subcutaneous progesterone rather than other regimens, and despite limited evidence for biological plausibility and a relatively small cohort (n1⁄4 57)—Melo et al. conclude that this regimen can harm FET implantation (Melo et al., 2022), which could potentially be misleading for patient and medical care providers. Melo et al. (2022) also stress the fact that their present study is the first on the topic that uses a prospective (though not randomized) design. Yet all studies—retrospective or prospective—rely, for the quality of their conclusion, on the data coming in. Melo et al.’s current study, while prospective, is indeed rather complex (Melo et al., 2022). Aside of being prospective and multicentric, it mixes several different protocols for timing FET without indicating the reasons retained by clinicians for choosing a particular approach. Furthermore, it combines single and multiple embryo transfers and, for HRT regimens, limited information on the use or not of prior pituitary desensitization. Specifically, for the topic that attracted our attention, the link between serum progesterone levels and FET outcome in the 57 women primed with subcutaneous progesterone 25 mg BID, the authors do not tell us the motives that led them to opt for this HRT regimen option in these patients. Melo et al.’s findings of FET outcomes when timed with subcutaneous progesterone (LubionR ) 25 mg BID (Melo et al., 2022) are extremely puzzling with respect to long established knowledge on progesterone levels and implantation. In the natural cycle, Filicori et al. have reported that plasma progesterone reaches 35 ng/ml in the lutea
{"title":"Hiding in plain sight.","authors":"Paul Pirtea, Dominique de Ziegler, James Toner, Richard Scott, Jean-Marc Ayoubi","doi":"10.1093/hropen/hoad015","DOIUrl":"https://doi.org/10.1093/hropen/hoad015","url":null,"abstract":"We read with interest the article by Melo et al. regarding progesterone levels and ART outcomes in all regimens used for priming frozen embryo transfers (FET) (Melo et al., 2022). This article follows a slew of publications on the topic and a metaanalysis conducted by these very authors (Melo et al., 2021). According to the mustered studies, lower serum progesterone levels on, or near, the day of embryo transfer (ET) in women receiving vaginal progesterone are associated with poorer FET outcomes (Melo et al., 2021). The present article by Melo et al. is new in that it studies the links between serum progesterone levels and the outcomes in all forms of treatment used for priming FET (Melo et al., 2022). This also includes the situation when subcutaneous progesterone (LubionR ) 25 mg BID is used exclusively (Melo et al., 2022). In this particular case, the study shows a biphasic relationship between serum progesterone levels and FET outcome with a sharp decrease in outcome when serum progesterone exceeds 16.3 ng/ml on the day of ET (Melo et al., 2022). Based on their observation, the authors suggest that serum levels of progesterone that exceed this mark exert a counterproductive effect on embryo implantation. Aside from the weaknesses of their study—for instance, there is no indication as to why patients were prescribed HRT using exclusively subcutaneous progesterone rather than other regimens, and despite limited evidence for biological plausibility and a relatively small cohort (n1⁄4 57)—Melo et al. conclude that this regimen can harm FET implantation (Melo et al., 2022), which could potentially be misleading for patient and medical care providers. Melo et al. (2022) also stress the fact that their present study is the first on the topic that uses a prospective (though not randomized) design. Yet all studies—retrospective or prospective—rely, for the quality of their conclusion, on the data coming in. Melo et al.’s current study, while prospective, is indeed rather complex (Melo et al., 2022). Aside of being prospective and multicentric, it mixes several different protocols for timing FET without indicating the reasons retained by clinicians for choosing a particular approach. Furthermore, it combines single and multiple embryo transfers and, for HRT regimens, limited information on the use or not of prior pituitary desensitization. Specifically, for the topic that attracted our attention, the link between serum progesterone levels and FET outcome in the 57 women primed with subcutaneous progesterone 25 mg BID, the authors do not tell us the motives that led them to opt for this HRT regimen option in these patients. Melo et al.’s findings of FET outcomes when timed with subcutaneous progesterone (LubionR ) 25 mg BID (Melo et al., 2022) are extremely puzzling with respect to long established knowledge on progesterone levels and implantation. In the natural cycle, Filicori et al. have reported that plasma progesterone reaches 35 ng/ml in the lutea","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 3","pages":"hoad015"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10234701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9576470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Meng Wu, Qingqing Zhu, Yibao Huang, Weicheng Tang, Jun Dai, Yican Guo, Jiaqiang Xiong, Jinjin Zhang, Su Zhou, Fangfang Fu, Mingfu Wu, Shixuan Wang
Abstract STUDY QUESTION Does cancer itself, before any gonadotoxic treatment, affect ovarian function in reproductive-aged patients? SUMMARY ANSWER Our study revealed that women with cancer may have decreased ovarian reserve markers even before cancer therapy. WHAT IS KNOWN ALREADY With the field ‘oncofertility’ improving rapidly, cancer therapy-mediated ovarian damage is well characterized. However, there is a controversy about whether cancer itself affects ovarian function before gonadotoxic treatment. STUDY DESIGN, SIZE, DURATION We conducted a systematic meta-analysis investigating the association between cancer and ovarian function prior to gonadotoxic treatment. Titles or abstracts related to ovarian reserve (e.g. anti-Müllerian hormone (AMH), antral follicle count (AFC), or basal follicle-stimulating hormone (FSH)) combined with titles or abstracts related to the exposure (e.g. cancer*, oncolog*, or malignan*) were searched in PubMed, Embase, and Web of Science databases from inception to 1 February 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS We included cohort, case-control, and cross-sectional studies in English that examined ovarian reserve in reproductive-aged patients (18–45 years) with cancer compared to age-matched controls before cancer treatment. The quality of the included studies was assessed by ROBINS-I. Fixed or random effects were conducted to estimate standard or weighted mean difference (SMD or WMD, respectively) and CI. Heterogeneity was assessed by the Q test and I2 statistics, and publication bias was evaluated by Egger’s and Begg’s tests. MAIN RESULTS AND THE ROLE OF CHANCE The review identified 17 eligible studies for inclusion. The results showed that cancer patients had lower serum AMH levels compared to healthy controls (SMD = −0.19, 95% CI = −0.34 to −0.03, P = 0.001), especially women with hematological malignancies (SMD = −0.62, 95% CI = −0.99 to −0.24, P = 0.001). The AFC was also decreased in patients with cancer (WMD = −0.93, 95% CI = −1.79 to −0.07, P = 0.033) compared to controls, while inhibin B and basal FSH levels showed no statistically significant differences. LIMITATIONS, REASONS FOR CAUTION Serum AMH and basal FSH levels in this meta-analysis showed high heterogeneity, and the small number of studies contributing to most subgroup analyses limited the heterogeneity analysis. Moreover, the studies for specific cancer subtypes may be too small to draw conclusions; more studies are needed to investigate the possible impact of cancer type and stage on ovarian function. WIDER IMPLICATIONS OF THE FINDINGS Our study confirmed the findings that cancer per se, especially hematological malignancies, negatively affects serum AMH level, and AFC values of reproductive-aged women. However, the lower AMH levels and AFC values may also be due to the changes in ovarian physiology under oncological conditions, rather than actual lower ovarian reserves. Based on the meta-analysis, clinicians should raise awareness abo
研究问题:在任何促性腺毒素治疗之前，癌症本身是否会影响育龄患者的卵巢功能?摘要回答:我们的研究表明，患有癌症的女性甚至在癌症治疗前卵巢储备标志物就可能下降。已知情况:随着“肿瘤生育”领域的迅速发展，癌症治疗介导的卵巢损伤得到了很好的表征。然而，在促性腺毒素治疗前，癌症本身是否会影响卵巢功能存在争议。研究设计规模持续时间:我们进行了一项系统的荟萃分析，调查促性腺毒素治疗前癌症与卵巢功能之间的关系。在PubMed、Embase和Web of Science数据库中检索从成立到2022年2月1日期间与卵巢储备相关的标题或摘要(如抗卵泡激素(AMH)、窦卵泡计数(AFC)或基底促卵泡激素(FSH))以及与暴露相关的标题或摘要(如cancer*、oncolog*或malignant *)。参与者/材料设置方法:我们纳入了队列研究、病例对照研究和英语横断面研究，这些研究检查了癌症治疗前育龄患者(18-45岁)与年龄匹配的对照组的卵巢储备。采用ROBINS-I评估纳入研究的质量。采用固定效应或随机效应来估计标准或加权平均差(分别为SMD或WMD)和CI。异质性采用Q检验和I2统计量评估，发表偏倚采用Egger’s和Begg’s检验评估。主要结果和偶然性的作用:本综述确定了17项符合纳入条件的研究。结果显示，与健康对照相比，癌症患者的血清AMH水平较低(SMD = -0.19, 95% CI = -0.34 ~ -0.03, P = 0.001)，特别是患有血液恶性肿瘤的女性(SMD = -0.62, 95% CI = -0.99 ~ -0.24, P = 0.001)。与对照组相比，癌症患者的AFC也降低(WMD = -0.93, 95% CI = -1.79 ~ -0.07, P = 0.033)，而抑制素B和基础FSH水平无统计学差异。局限性:本荟萃分析中血清AMH和基础FSH水平显示出较高的异质性，并且对大多数亚组分析的研究数量较少，限制了异质性分析。此外，针对特定癌症亚型的研究可能规模太小，无法得出结论;需要更多的研究来调查癌症类型和分期对卵巢功能的可能影响。研究结果的更广泛意义:我们的研究证实了癌症本身，特别是血液恶性肿瘤，对育龄妇女的血清AMH水平和AFC值产生负面影响。然而，较低的AMH水平和AFC值也可能是由于肿瘤条件下卵巢生理的变化，而不是卵巢储备的实际降低。基于荟萃分析，临床医生应该提高对在抗癌治疗前有兴趣追求生育保护策略的年轻癌症女性可能需要个性化方法的认识。研究经费/利益竞争:国家自然科学基金项目(81873824、82001514、81902669)和武汉市科技局应用基础研究计划项目(2019020701011436)资助。作者声明他们没有利益冲突。注册号:普洛斯彼罗(CRD42021235954)。
{"title":"Ovarian reserve in reproductive-aged patients with cancer before gonadotoxic treatment: a systematic review and meta-analysis.","authors":"Meng Wu, Qingqing Zhu, Yibao Huang, Weicheng Tang, Jun Dai, Yican Guo, Jiaqiang Xiong, Jinjin Zhang, Su Zhou, Fangfang Fu, Mingfu Wu, Shixuan Wang","doi":"10.1093/hropen/hoad024","DOIUrl":"https://doi.org/10.1093/hropen/hoad024","url":null,"abstract":"Abstract STUDY QUESTION Does cancer itself, before any gonadotoxic treatment, affect ovarian function in reproductive-aged patients? SUMMARY ANSWER Our study revealed that women with cancer may have decreased ovarian reserve markers even before cancer therapy. WHAT IS KNOWN ALREADY With the field ‘oncofertility’ improving rapidly, cancer therapy-mediated ovarian damage is well characterized. However, there is a controversy about whether cancer itself affects ovarian function before gonadotoxic treatment. STUDY DESIGN, SIZE, DURATION We conducted a systematic meta-analysis investigating the association between cancer and ovarian function prior to gonadotoxic treatment. Titles or abstracts related to ovarian reserve (e.g. anti-Müllerian hormone (AMH), antral follicle count (AFC), or basal follicle-stimulating hormone (FSH)) combined with titles or abstracts related to the exposure (e.g. cancer*, oncolog*, or malignan*) were searched in PubMed, Embase, and Web of Science databases from inception to 1 February 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS We included cohort, case-control, and cross-sectional studies in English that examined ovarian reserve in reproductive-aged patients (18–45 years) with cancer compared to age-matched controls before cancer treatment. The quality of the included studies was assessed by ROBINS-I. Fixed or random effects were conducted to estimate standard or weighted mean difference (SMD or WMD, respectively) and CI. Heterogeneity was assessed by the Q test and I2 statistics, and publication bias was evaluated by Egger’s and Begg’s tests. MAIN RESULTS AND THE ROLE OF CHANCE The review identified 17 eligible studies for inclusion. The results showed that cancer patients had lower serum AMH levels compared to healthy controls (SMD = −0.19, 95% CI = −0.34 to −0.03, P = 0.001), especially women with hematological malignancies (SMD = −0.62, 95% CI = −0.99 to −0.24, P = 0.001). The AFC was also decreased in patients with cancer (WMD = −0.93, 95% CI = −1.79 to −0.07, P = 0.033) compared to controls, while inhibin B and basal FSH levels showed no statistically significant differences. LIMITATIONS, REASONS FOR CAUTION Serum AMH and basal FSH levels in this meta-analysis showed high heterogeneity, and the small number of studies contributing to most subgroup analyses limited the heterogeneity analysis. Moreover, the studies for specific cancer subtypes may be too small to draw conclusions; more studies are needed to investigate the possible impact of cancer type and stage on ovarian function. WIDER IMPLICATIONS OF THE FINDINGS Our study confirmed the findings that cancer per se, especially hematological malignancies, negatively affects serum AMH level, and AFC values of reproductive-aged women. However, the lower AMH levels and AFC values may also be due to the changes in ovarian physiology under oncological conditions, rather than actual lower ovarian reserves. Based on the meta-analysis, clinicians should raise awareness abo","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 3","pages":"hoad024"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10266964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9657334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Study question: </strong>Are dietary phytochemicals associated with the risk of teratozoospermia?</p><p><strong>Summary answer: </strong>Dietary intake of carotene, including total carotene, α-carotene, β-carotene as well as retinol equivalent, and lutein + zeaxanthin, were inversely correlated with the risk of teratozoospermia.</p><p><strong>What is known already: </strong>Phytochemicals are natural plant derived bioactive compounds, which have been reported to be potentially associated with male reproductive health. To date, no study has investigated the association between phytochemical intake and the risk of teratozoospermia.</p><p><strong>Study design size duration: </strong>This hospital-based case-control study, which included 146 newly diagnosed teratozoospermia cases and 581 controls with normozoospermia from infertile couples, was conducted in a hospital-based infertility clinic in China, from June 2020 to December 2020.</p><p><strong>Participants/materials setting methods: </strong>Dietary information was collected using a validated semi-quantitative 110-item food frequency questionnaire. Unconditional logistic regression was applied to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between phytochemical (i.e. phytosterol, carotene, flavonoid, isoflavone, anthocyanidin, lutein + zeaxanthin, and resveratrol) intake and the risk of teratozoospermia.</p><p><strong>Main results and the role of chance: </strong>We observed a decreased risk of teratozoospermia for the highest compared with the lowest tertile consumption of total carotene (OR = 0.40, 95% CI = 0.21-0.77), α-carotene (OR = 0.53, 95% CI = 0.30-0.93), β-carotene (OR = 0.47, 95% CI = 0.25-0.88), retinol equivalent (OR = 0.47, 95% CI = 0.24-0.90), and lutein + zeaxanthin (OR = 0.35, 95% CI = 0.19-0.66), with all of the associations showing evident linear trends (all <i>P</i> trend <0.05). In addition, significant dose-response associations were observed between campestanol and α-carotene consumption and the risk of teratozoospermia. Moreover, there was a significant multiplicative interaction between BMI and lutein + zeaxanthin intake (<i>P</i> interaction <0.05).</p><p><strong>Limitations reasons for caution: </strong>The cases and controls were not a random sample of the entire target population, which could lead to admission rate bias. Nevertheless, the controls were enrolled from the same infertility clinic, which could reduce the bias caused by selection and increase the comparability. Furthermore, our study only included a Chinese population, therefore caution is required regarding generalization of our findings to other populations.</p><p><strong>Wider implications of the findings: </strong>Dietary phytochemicals, namely carotene, lutein, and zeaxanthin, might exert a positive effect on teratozoospermia. These phytochemicals are common in the daily diet and dietary supplements, and thus may provide a preventive intervention for
研究问题:饮食中的植物化学物质与患畸形精子症的风险有关吗?总结回答:膳食中总胡萝卜素、α-胡萝卜素、β-胡萝卜素及视黄醇当量、叶黄素+玉米黄质的摄入量与畸形儿精子症的风险呈负相关。已知情况:植物化学物质是天然植物衍生的生物活性化合物，据报道可能与男性生殖健康有关。到目前为止，还没有研究调查植物化学物质摄入与畸形精子症风险之间的关系。研究设计规模持续时间:这项以医院为基础的病例对照研究于2020年6月至2020年12月在中国一家医院不育诊所进行，包括146例新诊断的畸形精子症病例和581例正常精子症对照。参与者/材料设置方法:采用半定量的110项食物频率问卷收集饮食信息。应用无条件logistic回归来估计植物化学物质(即植物甾醇、胡萝卜素、类黄酮、异黄酮、花青素、叶黄素+玉米黄质和白藜芦醇)摄入与畸形精子症风险之间的比值比(ORs)和95%置信区间(CIs)。主要结果和机会的作用:我们观察到的风险减少畸形的最高与最低tertile消费总胡萝卜素(或= 0.40,95% CI -0.77 = 0.21),α-胡萝卜素(或= 0.53,95% CI -0.93 = 0.30),β-胡萝卜素(或= 0.47,95% CI -0.88 = 0.25),视黄醇当量(或= 0.47,95% CI = 0.24 - -0.90),和叶黄素和玉米黄质(或= 0.35,95% CI -0.66 = 0.19),所有的关联显示明显的线性趋势(所有P趋势P交互的局限性原因警告:病例和对照不是整个目标人群的随机样本，这可能导致入院率偏差。然而，对照组来自同一家不育诊所，这可以减少选择造成的偏倚，增加可比性。此外，我们的研究仅包括中国人群，因此需要谨慎地将我们的研究结果推广到其他人群。研究结果的更广泛含义:膳食中的植物化学物质，即胡萝卜素、叶黄素和玉米黄质，可能对畸形精子症产生积极影响。这些植物化学物质在日常饮食和膳食补充剂中很常见，因此可能对畸形精子症提供预防性干预。研究经费/利益竞争:本研究由辽宁省自然科学基金(No. 2022-MS-219 to X.B.W.)、盛京医院优秀科学基金(No. 202ms -219 to X.B.W.)资助。M1150 - q.j.w)，盛京医院临床科研培养项目(No. 1150);项目编号:M0071 - B.C.P.)，辽宁省揭邦瓜帅项目(2021JH1/1040050 - y.h.z)。所有作者都声明不存在利益冲突。试验注册号:无。
{"title":"Phytochemical consumption and the risk of teratozoospermia: findings from a hospital-based case-control study in China.","authors":"Jun-Qi Zhao, Jia-Le Lv, Xiao-Bin Wang, Yi-Fan Wei, Ren-Hao Guo, Xu Leng, Qiang Du, Dong-Hui Huang, Qi-Jun Wu, Bo-Chen Pan, Yu-Hong Zhao","doi":"10.1093/hropen/hoad025","DOIUrl":"https://doi.org/10.1093/hropen/hoad025","url":null,"abstract":"<p><strong>Study question: </strong>Are dietary phytochemicals associated with the risk of teratozoospermia?</p><p><strong>Summary answer: </strong>Dietary intake of carotene, including total carotene, α-carotene, β-carotene as well as retinol equivalent, and lutein + zeaxanthin, were inversely correlated with the risk of teratozoospermia.</p><p><strong>What is known already: </strong>Phytochemicals are natural plant derived bioactive compounds, which have been reported to be potentially associated with male reproductive health. To date, no study has investigated the association between phytochemical intake and the risk of teratozoospermia.</p><p><strong>Study design size duration: </strong>This hospital-based case-control study, which included 146 newly diagnosed teratozoospermia cases and 581 controls with normozoospermia from infertile couples, was conducted in a hospital-based infertility clinic in China, from June 2020 to December 2020.</p><p><strong>Participants/materials setting methods: </strong>Dietary information was collected using a validated semi-quantitative 110-item food frequency questionnaire. Unconditional logistic regression was applied to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the associations between phytochemical (i.e. phytosterol, carotene, flavonoid, isoflavone, anthocyanidin, lutein + zeaxanthin, and resveratrol) intake and the risk of teratozoospermia.</p><p><strong>Main results and the role of chance: </strong>We observed a decreased risk of teratozoospermia for the highest compared with the lowest tertile consumption of total carotene (OR = 0.40, 95% CI = 0.21-0.77), α-carotene (OR = 0.53, 95% CI = 0.30-0.93), β-carotene (OR = 0.47, 95% CI = 0.25-0.88), retinol equivalent (OR = 0.47, 95% CI = 0.24-0.90), and lutein + zeaxanthin (OR = 0.35, 95% CI = 0.19-0.66), with all of the associations showing evident linear trends (all <i>P</i> trend <0.05). In addition, significant dose-response associations were observed between campestanol and α-carotene consumption and the risk of teratozoospermia. Moreover, there was a significant multiplicative interaction between BMI and lutein + zeaxanthin intake (<i>P</i> interaction <0.05).</p><p><strong>Limitations reasons for caution: </strong>The cases and controls were not a random sample of the entire target population, which could lead to admission rate bias. Nevertheless, the controls were enrolled from the same infertility clinic, which could reduce the bias caused by selection and increase the comparability. Furthermore, our study only included a Chinese population, therefore caution is required regarding generalization of our findings to other populations.</p><p><strong>Wider implications of the findings: </strong>Dietary phytochemicals, namely carotene, lutein, and zeaxanthin, might exert a positive effect on teratozoospermia. These phytochemicals are common in the daily diet and dietary supplements, and thus may provide a preventive intervention for ","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 3","pages":"hoad025"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/19/07/hoad025.PMC10279649.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9710258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Siddharth Pattnaik, Dipankar Das, Varun Akur Venkatesan, Aayush Rai
Study question: Can a home-use device be used to predict serum hormone levels?
Summary answer: A home-use device can predict urinary hormone values which are well-correlated to serum concentrations of respective hormones and hence can be used as a proxy for serum measurements.
What is known already: Home-use devices that predict ovulation are calibrated against the actual day of ovulation. However, the correlation of any quantitative system to serum hormone concentrations has not been established.
Study design size duration: A total of 73 data points obtained from 20 participants across different phases of the menstrual cycle, i.e. bleeding days, follicular phase and luteal phase were used to establish the correlation between serum hormones and urinary metabolite values. Single data points from 20 random users were used to assess the correlation established.
Participants/materials setting methods: Participants were women in the fertile age groups and only current users of the home-use device. Selection was done based on inclusion and exclusion criteria. Blood hormones were tested using chemiluminescent immunoassays and urinary measurements were taken on the home-use device at home.
Main results and the role of chance: Serum estradiol (E2), progesterone (P4) and LH were correlated with urinary estrone-3-glucuronide (E3G), pregnanediol glucuronide (PdG) and LH with an R2 of 0.96, 0.95 and 0.98, respectively. Repredicted serum concentration obtained by using the correlation equation had a correlation of 0.92, 0.94 and 0.93 in unknown samples.
Limitations reasons for caution: The study was designed to include women who have normal cycle lengths regularly; therefore, the values obtained were in the normal range. Certain infertility conditions may cause the values to be higher and correlation in such cases needs to be established.
Wider implications of the findings: The results of this study imply a new tool that can be used by fertility specialists as a proxy for blood tests whenever required. Extended study on this system can enable its use in assisted reproductive techniques as well.
Study funding/competing interests: No funding was received for this study. S.P. and D.D. are employees of the research and development division of Samplytics Technologies Pvt. Ltd. which is a forwarder for Inito Inc., USA. A.R. and V.A.V. are co-founders of Inito Inc., USA.
Trial registration number: The trial was registered at the International Standard Randomised Controlled Trial Number (ISRCTN) registry (Identifier: ISRCTN15534557).
{"title":"Predicting serum hormone concentration by estimation of urinary hormones through a home-use device.","authors":"Siddharth Pattnaik, Dipankar Das, Varun Akur Venkatesan, Aayush Rai","doi":"10.1093/hropen/hoac058","DOIUrl":"https://doi.org/10.1093/hropen/hoac058","url":null,"abstract":"<p><strong>Study question: </strong>Can a home-use device be used to predict serum hormone levels?</p><p><strong>Summary answer: </strong>A home-use device can predict urinary hormone values which are well-correlated to serum concentrations of respective hormones and hence can be used as a proxy for serum measurements.</p><p><strong>What is known already: </strong>Home-use devices that predict ovulation are calibrated against the actual day of ovulation. However, the correlation of any quantitative system to serum hormone concentrations has not been established.</p><p><strong>Study design size duration: </strong>A total of 73 data points obtained from 20 participants across different phases of the menstrual cycle, i.e. bleeding days, follicular phase and luteal phase were used to establish the correlation between serum hormones and urinary metabolite values. Single data points from 20 random users were used to assess the correlation established.</p><p><strong>Participants/materials setting methods: </strong>Participants were women in the fertile age groups and only current users of the home-use device. Selection was done based on inclusion and exclusion criteria. Blood hormones were tested using chemiluminescent immunoassays and urinary measurements were taken on the home-use device at home.</p><p><strong>Main results and the role of chance: </strong>Serum estradiol (E2), progesterone (P4) and LH were correlated with urinary estrone-3-glucuronide (E3G), pregnanediol glucuronide (PdG) and LH with an <i>R</i> <sup>2</sup> of 0.96, 0.95 and 0.98, respectively. Repredicted serum concentration obtained by using the correlation equation had a correlation of 0.92, 0.94 and 0.93 in unknown samples.</p><p><strong>Limitations reasons for caution: </strong>The study was designed to include women who have normal cycle lengths regularly; therefore, the values obtained were in the normal range. Certain infertility conditions may cause the values to be higher and correlation in such cases needs to be established.</p><p><strong>Wider implications of the findings: </strong>The results of this study imply a new tool that can be used by fertility specialists as a proxy for blood tests whenever required. Extended study on this system can enable its use in assisted reproductive techniques as well.</p><p><strong>Study funding/competing interests: </strong>No funding was received for this study. S.P. and D.D. are employees of the research and development division of Samplytics Technologies Pvt. Ltd. which is a forwarder for Inito Inc., USA. A.R. and V.A.V. are co-founders of Inito Inc., USA.</p><p><strong>Trial registration number: </strong>The trial was registered at the International Standard Randomised Controlled Trial Number (ISRCTN) registry (Identifier: ISRCTN15534557).</p>","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 1","pages":"hoac058"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/54/4a/hoac058.PMC9838318.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10604153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Catello Scarica, Bryan J Woodward, Lucia De Santis, Borut Kovačič
<p><strong>Study question: </strong>How is the acquisition and testing of theoretical and practical knowledge in Clinical Embryology and the licensing of ART laboratory personnel carried out in European countries?</p><p><strong>Summary answer: </strong>Twelve out of 31 European countries have established some kind of verification of laboratory competency and skills in ART: in 7 countries, this was related to licensing, but where organized education for Clinical Embryologists existed, there were vast differences in the way these processes were undertaken.</p><p><strong>What is known already: </strong>In 2015, a report by the ESHRE Embryology Certification Committee concluded that regardless of the large number of people working in IVF laboratories, Clinical Embryology was only recognized as an official profession in 3 out of 27 European national health systems. In most countries, Clinical Embryologists needed to be officially registered under an alternative profession and there were limited opportunities for organized education in this specialist field. Five years after this report, the ESHRE Working Group on Embryologist Training Analysis conducted a survey to collect detailed information about how Clinical Embryologists from different European countries are acquiring their theoretical knowledge and practical skills in ART, and how their level of education and competence in Clinical Embryology is verified.</p><p><strong>Study design size duration: </strong>Two questionnaires about the possibilities for acquiring the education and training needed to work in ART and verification of this knowledge were prepared by the ESHRE Working Group on Embryologist Training Analysis. The first was sent in 2020 to a panel of invited lead European Embryologists who attended an Expert Meeting held in Rome, Italy. In order to have a more comprehensive and updated picture, in 2021 the same survey was also sent to the ESHRE Committee of National Representatives (CNRs). At the end of 2021, the second survey with specific questions, more focused on Clinical Embryologists' training and licencing, was sent to the CNRs who reported on verification of education in Clinical Embryology.</p><p><strong>Participants/materials setting methods: </strong>The first survey consisted of 17 questions. It was initially submitted to 14 lead Embryologists and then resubmitted to the 34 ESHRE CNRs. Representatives from 31 countries responded. A second survey with 23 questions was sent to the 12 ESHRE CNRs who reported an established national system of verification of education in Clinical Embryology, with specific questions focused on the training of Clinical Embryologists. All 12 CNRs responded.</p><p><strong>Main results and the role of chance: </strong>Analysis showed that European national education programmes in Clinical Embryology could be split into 4 categories: non-existent (13 countries), recommended (5 countries), simple compulsory (9 countries), and complex compulsory (4 count
{"title":"Training and competency assessment of Clinical Embryologists and licensing of the profession in European countries.","authors":"Catello Scarica, Bryan J Woodward, Lucia De Santis, Borut Kovačič","doi":"10.1093/hropen/hoad001","DOIUrl":"https://doi.org/10.1093/hropen/hoad001","url":null,"abstract":"<p><strong>Study question: </strong>How is the acquisition and testing of theoretical and practical knowledge in Clinical Embryology and the licensing of ART laboratory personnel carried out in European countries?</p><p><strong>Summary answer: </strong>Twelve out of 31 European countries have established some kind of verification of laboratory competency and skills in ART: in 7 countries, this was related to licensing, but where organized education for Clinical Embryologists existed, there were vast differences in the way these processes were undertaken.</p><p><strong>What is known already: </strong>In 2015, a report by the ESHRE Embryology Certification Committee concluded that regardless of the large number of people working in IVF laboratories, Clinical Embryology was only recognized as an official profession in 3 out of 27 European national health systems. In most countries, Clinical Embryologists needed to be officially registered under an alternative profession and there were limited opportunities for organized education in this specialist field. Five years after this report, the ESHRE Working Group on Embryologist Training Analysis conducted a survey to collect detailed information about how Clinical Embryologists from different European countries are acquiring their theoretical knowledge and practical skills in ART, and how their level of education and competence in Clinical Embryology is verified.</p><p><strong>Study design size duration: </strong>Two questionnaires about the possibilities for acquiring the education and training needed to work in ART and verification of this knowledge were prepared by the ESHRE Working Group on Embryologist Training Analysis. The first was sent in 2020 to a panel of invited lead European Embryologists who attended an Expert Meeting held in Rome, Italy. In order to have a more comprehensive and updated picture, in 2021 the same survey was also sent to the ESHRE Committee of National Representatives (CNRs). At the end of 2021, the second survey with specific questions, more focused on Clinical Embryologists' training and licencing, was sent to the CNRs who reported on verification of education in Clinical Embryology.</p><p><strong>Participants/materials setting methods: </strong>The first survey consisted of 17 questions. It was initially submitted to 14 lead Embryologists and then resubmitted to the 34 ESHRE CNRs. Representatives from 31 countries responded. A second survey with 23 questions was sent to the 12 ESHRE CNRs who reported an established national system of verification of education in Clinical Embryology, with specific questions focused on the training of Clinical Embryologists. All 12 CNRs responded.</p><p><strong>Main results and the role of chance: </strong>Analysis showed that European national education programmes in Clinical Embryology could be split into 4 categories: non-existent (13 countries), recommended (5 countries), simple compulsory (9 countries), and complex compulsory (4 count","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 1","pages":"hoad001"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c9/10/hoad001.PMC9920573.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9287792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jeroen Metzemaekers, Lotte Bouwman, Marit de Vos, Kim van Nieuwenhuizen, Andries R H Twijnstra, Maddy Smeets, Frank Willem Jansen, Mathijs Blikkendaal
<p><strong>Study question: </strong>What is the additional value of the comprehensive complication index (CCI) and ClassIntra system (classification for intraoperative adverse events (ioAEs)) in adverse event (AE) reporting in (deep) endometriosis (DE) surgery compared to only using the Clavien-Dindo (CD) system?</p><p><strong>Summary answer: </strong>The CCI and ClassIntra are useful additional tools alongside the CD system for a complete and uniform overview of the total AE burden in patients with extensive surgery (such as DE), and with this uniform data registration, it is possible to provide greater insight into the quality of care.</p><p><strong>What is known already: </strong>Uniform comparison of AEs reported in the literature is hampered by scattered registration. In endometriosis surgery, the usage of the CD complication system and the CCI is internationally recommended; however, the CCI is not routinely adapted in endometriosis care and research. Furthermore, a recommendation for ioAEs registration in endometriosis surgery is lacking, although this is vital information in surgical quality assessments.</p><p><strong>Study design size duration: </strong>A prospective mono-center study was conducted with 870 surgical DE cases from a non-university DE expertise center between February 2019 and December 2021.</p><p><strong>Participants/materials setting methods: </strong>Endometriosis cases were collected with the EQUSUM system, a publicly available web-based application for registration of surgical procedures for endometriosis. Postoperative adverse events (poAEs) were classified with the CD complication system and CCI. Differences in reporting and classifying AEs between the CCI and the CD were assessed. ioAEs were assessed with the ClassIntra. The primary outcome measure was to assess the additional value toward the CD classification with the introduction of the CCI and ClassIntra. In addition, we report a benchmark for the CCI in DE surgery.</p><p><strong>Main results and the role of chance: </strong>A total of 870 DE procedures were registered, of which 145 procedures with one or more poAEs, resulting in a poAE rate of 16.7% (145/870), of which in 36 cases (4.1%), the poAE was classified as severe (≥Grade 3b). The median CCI (interquartile range) of patients with poAEs was 20.9 (20.9-31.7) and 33.7 (33.7-39.7) in the group of patients with severe poAEs. In 20 patients (13.8%), the CCI was higher than the CD because of multiple poAEs. There were 11 ioAEs reported (11/870, 1.3%) in all procedures, mostly minor and directly repaired serosa injuries.</p><p><strong>Limitations reasons for caution: </strong>This study was conducted at a single center; thus, trends in AE rates and type of AEs could differ from other centers. Furthermore, no conclusion could be drawn on ioAEs in relation to the postoperative course because the power of this database is not robust enough for that purpose.</p><p><strong>Wider implications of the findings: </stro
{"title":"Clavien-Dindo, comprehensive complication index and classification of intraoperative adverse events: a uniform and holistic approach in adverse event registration for (deep) endometriosis surgery.","authors":"Jeroen Metzemaekers, Lotte Bouwman, Marit de Vos, Kim van Nieuwenhuizen, Andries R H Twijnstra, Maddy Smeets, Frank Willem Jansen, Mathijs Blikkendaal","doi":"10.1093/hropen/hoad019","DOIUrl":"https://doi.org/10.1093/hropen/hoad019","url":null,"abstract":"<p><strong>Study question: </strong>What is the additional value of the comprehensive complication index (CCI) and ClassIntra system (classification for intraoperative adverse events (ioAEs)) in adverse event (AE) reporting in (deep) endometriosis (DE) surgery compared to only using the Clavien-Dindo (CD) system?</p><p><strong>Summary answer: </strong>The CCI and ClassIntra are useful additional tools alongside the CD system for a complete and uniform overview of the total AE burden in patients with extensive surgery (such as DE), and with this uniform data registration, it is possible to provide greater insight into the quality of care.</p><p><strong>What is known already: </strong>Uniform comparison of AEs reported in the literature is hampered by scattered registration. In endometriosis surgery, the usage of the CD complication system and the CCI is internationally recommended; however, the CCI is not routinely adapted in endometriosis care and research. Furthermore, a recommendation for ioAEs registration in endometriosis surgery is lacking, although this is vital information in surgical quality assessments.</p><p><strong>Study design size duration: </strong>A prospective mono-center study was conducted with 870 surgical DE cases from a non-university DE expertise center between February 2019 and December 2021.</p><p><strong>Participants/materials setting methods: </strong>Endometriosis cases were collected with the EQUSUM system, a publicly available web-based application for registration of surgical procedures for endometriosis. Postoperative adverse events (poAEs) were classified with the CD complication system and CCI. Differences in reporting and classifying AEs between the CCI and the CD were assessed. ioAEs were assessed with the ClassIntra. The primary outcome measure was to assess the additional value toward the CD classification with the introduction of the CCI and ClassIntra. In addition, we report a benchmark for the CCI in DE surgery.</p><p><strong>Main results and the role of chance: </strong>A total of 870 DE procedures were registered, of which 145 procedures with one or more poAEs, resulting in a poAE rate of 16.7% (145/870), of which in 36 cases (4.1%), the poAE was classified as severe (≥Grade 3b). The median CCI (interquartile range) of patients with poAEs was 20.9 (20.9-31.7) and 33.7 (33.7-39.7) in the group of patients with severe poAEs. In 20 patients (13.8%), the CCI was higher than the CD because of multiple poAEs. There were 11 ioAEs reported (11/870, 1.3%) in all procedures, mostly minor and directly repaired serosa injuries.</p><p><strong>Limitations reasons for caution: </strong>This study was conducted at a single center; thus, trends in AE rates and type of AEs could differ from other centers. Furthermore, no conclusion could be drawn on ioAEs in relation to the postoperative course because the power of this database is not robust enough for that purpose.</p><p><strong>Wider implications of the findings: </stro","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 2","pages":"hoad019"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10224795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9545712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A J Adeleye, L Zablotska, P Rinaudo, D Huang, R H Lustig, M I Cedars
<p><strong>Study questions: </strong>The primary objective of this study is to determine what parental factors or specific ART may influence the risk for adverse cardiometabolic outcomes among children so conceived and their parents. The secondary objective of this study is to prospectively examine the effects of infertility or ART on the intrauterine environment, obstetric and neonatal outcomes.</p><p><strong>What is known already: </strong>Pregnancies conceived with ART are at an increased risk of being affected by adverse obstetric and neonatal outcomes when compared to spontaneously conceived (SC) pregnancies among fertile women. Small cohort studies have suggested ART-conceived children may have a higher risk of long-term cardiometabolic disturbances as well. Currently, few studies have compared long-term cardiometabolic outcomes among ART-conceived children and non-IVF treated (NIFT) children, to children conceived spontaneously to parents with infertility (subfertile parents).</p><p><strong>Study design size duration: </strong>The Developmental Epidemiological Study of Children born through Reproductive Technologies (DESCRT) is a prospective cohort study that aims to: establish a biobank and epidemiological cohort of children born to subfertile or infertile parents who either conceived spontaneously (without assistance) or used reproductive technologies to conceive (all offspring were from couples assessed and/or treated in the same institute); prospectively examine the effects of infertility or ART on the intrauterine environment, obstetric and neonatal outcomes; and determine what parental factors or ART may influence the cardiometabolic risk of children so conceived. Pregnancies and resultant children will be compared by mode of conception, namely offspring that were conceived without medical assistance or SC or following NIFT, IVF with fresh embryo transfer or frozen embryo transfer (FET), and by fertilization method (conventional versus ICSI). DESCRT has a Child group evaluating long-term outcomes of children as well as a Pregnancy group that will compare obstetric and neonatal outcomes of children conceived since the commencement of the study. Recruitment started in May of 2017 and is ongoing. When the study began, we estimated that ∼4000 children would be eligible for enrollment.</p><p><strong>Participants/materials setting methods: </strong>Eligible participants are first-trimester pregnancies (Pregnancy group) or children (Child group) born to parents who were evaluated at an infertility center in the University of California, San Francisco, CA, USA who were SC or conceived after reproductive treatments (NIFT, IVF ± ICSI, FET). Children in the Child group were conceived at UCSF and born from 2001 onwards. In the Pregnancy group, enrollment began in November of 2017.The primary outcome is the cardiometabolic health of offspring in the Child group, as measured by blood pressure and laboratory data (homeostatic model assessment for i
{"title":"Study protocol for a Developmental Epidemiological Study of Children born through Reproductive Technologies (DESCRT).","authors":"A J Adeleye, L Zablotska, P Rinaudo, D Huang, R H Lustig, M I Cedars","doi":"10.1093/hropen/hoad013","DOIUrl":"https://doi.org/10.1093/hropen/hoad013","url":null,"abstract":"<p><strong>Study questions: </strong>The primary objective of this study is to determine what parental factors or specific ART may influence the risk for adverse cardiometabolic outcomes among children so conceived and their parents. The secondary objective of this study is to prospectively examine the effects of infertility or ART on the intrauterine environment, obstetric and neonatal outcomes.</p><p><strong>What is known already: </strong>Pregnancies conceived with ART are at an increased risk of being affected by adverse obstetric and neonatal outcomes when compared to spontaneously conceived (SC) pregnancies among fertile women. Small cohort studies have suggested ART-conceived children may have a higher risk of long-term cardiometabolic disturbances as well. Currently, few studies have compared long-term cardiometabolic outcomes among ART-conceived children and non-IVF treated (NIFT) children, to children conceived spontaneously to parents with infertility (subfertile parents).</p><p><strong>Study design size duration: </strong>The Developmental Epidemiological Study of Children born through Reproductive Technologies (DESCRT) is a prospective cohort study that aims to: establish a biobank and epidemiological cohort of children born to subfertile or infertile parents who either conceived spontaneously (without assistance) or used reproductive technologies to conceive (all offspring were from couples assessed and/or treated in the same institute); prospectively examine the effects of infertility or ART on the intrauterine environment, obstetric and neonatal outcomes; and determine what parental factors or ART may influence the cardiometabolic risk of children so conceived. Pregnancies and resultant children will be compared by mode of conception, namely offspring that were conceived without medical assistance or SC or following NIFT, IVF with fresh embryo transfer or frozen embryo transfer (FET), and by fertilization method (conventional versus ICSI). DESCRT has a Child group evaluating long-term outcomes of children as well as a Pregnancy group that will compare obstetric and neonatal outcomes of children conceived since the commencement of the study. Recruitment started in May of 2017 and is ongoing. When the study began, we estimated that ∼4000 children would be eligible for enrollment.</p><p><strong>Participants/materials setting methods: </strong>Eligible participants are first-trimester pregnancies (Pregnancy group) or children (Child group) born to parents who were evaluated at an infertility center in the University of California, San Francisco, CA, USA who were SC or conceived after reproductive treatments (NIFT, IVF ± ICSI, FET). Children in the Child group were conceived at UCSF and born from 2001 onwards. In the Pregnancy group, enrollment began in November of 2017.The primary outcome is the cardiometabolic health of offspring in the Child group, as measured by blood pressure and laboratory data (homeostatic model assessment for i","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 2","pages":"hoad013"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10229433/pdf/hoad013.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9568855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ruth Bender Atik, Ole Bjarne Christiansen, Janine Elson, Astrid Marie Kolte, Sheena Lewis, Saskia Middeldorp, Saria Mcheik, Braulio Peramo, Siobhan Quenby, Henriette Svarre Nielsen, Marie-Louise van der Hoorn, Nathalie Vermeulen, Mariëtte Goddijn
<p><strong>Study question: </strong>What are the updates for the recommended management of women with recurrent pregnancy loss (RPL) based on the best available evidence in the literature from 2017 to 2022?</p><p><strong>Summary answer: </strong>The guideline development group (GDG) updated 11 existing recommendations on investigations and treatments for RPL, and how care should be organized, and added one new recommendation on adenomyosis investigation in women with RPL.</p><p><strong>What is known already: </strong>A previous ESHRE guideline on RPL was published in 2017 and needs to be updated.</p><p><strong>Study design size duration: </strong>The guideline was developed and updated according to the structured methodology for development and update of ESHRE guidelines. The literature searches were updated, and assessments of relevant new evidence were performed. Relevant papers published between 31 March 2017 and 28 February 2022 and written in English were included. Cumulative live birth rate, live birth rate, and pregnancy loss rate (or miscarriage rate) were considered the critical outcomes.</p><p><strong>Participants/materials setting methods: </strong>Based on the collected evidence, recommendations were updated and discussed until consensus was reached within the GDG. A stakeholder review was organized after the updated draft was finalized. The final version was approved by the GDG and the ESHRE Executive Committee.</p><p><strong>Main results and the role of chance: </strong>The new version of the guideline provides 39 recommendations on risk factors, prevention, and investigation in couples with RPL, and 38 recommendations on treatments. These includes 62 evidence-based recommendations-of which 33 were formulated as strong recommendations and 29 as conditional-and 15 good practice points. Of the evidence-based recommendations, 12 (19.4%) were supported by moderate-quality evidence. The remaining recommendations were supported by low (34 recommendations; 54.8%), or very low-quality evidence (16 recommendations; 25.8%). Owing to the lack of evidence-based investigations and treatments in RPL care, the guideline also clearly mentions those investigations and treatments that should not be used for couples with RPL.</p><p><strong>Limitations reasons for caution: </strong>The guidelines have been updated; however, several investigations and treatments currently offered to couples with RPL have not been well studied; for most of these investigations and treatments, a recommendation against using the intervention or treatment was formulated based on insufficient evidence. Future studies may require these recommendations to be revised.</p><p><strong>Wider implications of the findings: </strong>The guideline provides clinicians with clear advice on best practice in RPL, based on the best and most recent evidence available. In addition, a list of research recommendations is provided to stimulate further studies in RPL. Still, the absence of a unif
{"title":"ESHRE guideline: recurrent pregnancy loss: an update in 2022.","authors":"Ruth Bender Atik, Ole Bjarne Christiansen, Janine Elson, Astrid Marie Kolte, Sheena Lewis, Saskia Middeldorp, Saria Mcheik, Braulio Peramo, Siobhan Quenby, Henriette Svarre Nielsen, Marie-Louise van der Hoorn, Nathalie Vermeulen, Mariëtte Goddijn","doi":"10.1093/hropen/hoad002","DOIUrl":"https://doi.org/10.1093/hropen/hoad002","url":null,"abstract":"<p><strong>Study question: </strong>What are the updates for the recommended management of women with recurrent pregnancy loss (RPL) based on the best available evidence in the literature from 2017 to 2022?</p><p><strong>Summary answer: </strong>The guideline development group (GDG) updated 11 existing recommendations on investigations and treatments for RPL, and how care should be organized, and added one new recommendation on adenomyosis investigation in women with RPL.</p><p><strong>What is known already: </strong>A previous ESHRE guideline on RPL was published in 2017 and needs to be updated.</p><p><strong>Study design size duration: </strong>The guideline was developed and updated according to the structured methodology for development and update of ESHRE guidelines. The literature searches were updated, and assessments of relevant new evidence were performed. Relevant papers published between 31 March 2017 and 28 February 2022 and written in English were included. Cumulative live birth rate, live birth rate, and pregnancy loss rate (or miscarriage rate) were considered the critical outcomes.</p><p><strong>Participants/materials setting methods: </strong>Based on the collected evidence, recommendations were updated and discussed until consensus was reached within the GDG. A stakeholder review was organized after the updated draft was finalized. The final version was approved by the GDG and the ESHRE Executive Committee.</p><p><strong>Main results and the role of chance: </strong>The new version of the guideline provides 39 recommendations on risk factors, prevention, and investigation in couples with RPL, and 38 recommendations on treatments. These includes 62 evidence-based recommendations-of which 33 were formulated as strong recommendations and 29 as conditional-and 15 good practice points. Of the evidence-based recommendations, 12 (19.4%) were supported by moderate-quality evidence. The remaining recommendations were supported by low (34 recommendations; 54.8%), or very low-quality evidence (16 recommendations; 25.8%). Owing to the lack of evidence-based investigations and treatments in RPL care, the guideline also clearly mentions those investigations and treatments that should not be used for couples with RPL.</p><p><strong>Limitations reasons for caution: </strong>The guidelines have been updated; however, several investigations and treatments currently offered to couples with RPL have not been well studied; for most of these investigations and treatments, a recommendation against using the intervention or treatment was formulated based on insufficient evidence. Future studies may require these recommendations to be revised.</p><p><strong>Wider implications of the findings: </strong>The guideline provides clinicians with clear advice on best practice in RPL, based on the best and most recent evidence available. In addition, a list of research recommendations is provided to stimulate further studies in RPL. Still, the absence of a unif","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 1","pages":"hoad002"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c4/4d/hoad002.PMC9982362.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9869742","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
D Cimadomo, M J de Los Santos, G Griesinger, G Lainas, N Le Clef, D J McLernon, D Montjean, B Toth, N Vermeulen, N Macklon
<p><strong>Study question: </strong>How should recurrent implantation failure (RIF) in patients undergoing ART be defined and managed?</p><p><strong>Summary answer: </strong>This is the first ESHRE good practice recommendations paper providing a definition for RIF together with recommendations on how to investigate causes and contributing factors, and how to improve the chances of a pregnancy.</p><p><strong>What is known already: </strong>RIF is a challenge in the ART clinic, with a multitude of investigations and interventions offered and applied in clinical practice, often without biological rationale or with unequivocal evidence of benefit.</p><p><strong>Study design size duration: </strong>This document was developed according to a predefined methodology for ESHRE good practice recommendations. Recommendations are supported by data from the literature, if available, and the results of a previously published survey on clinical practice in RIF and the expertise of the working group. A literature search was performed in PubMed and Cochrane focussing on 'recurrent reproductive failure', 'recurrent implantation failure', and 'repeated implantation failure'.</p><p><strong>Participants/materials setting methods: </strong>The ESHRE Working Group on Recurrent Implantation Failure included eight members representing the ESHRE Special Interest Groups for Implantation and Early Pregnancy, Reproductive Endocrinology, and Embryology, with an independent chair and an expert in statistics. The recommendations for clinical practice were formulated based on the expert opinion of the working group, while taking into consideration the published data and results of the survey on uptake in clinical practice. The draft document was then open to ESHRE members for online peer review and was revised in light of the comments received.</p><p><strong>Main results and the role of chance: </strong>The working group recommends considering RIF as a secondary phenomenon of ART, as it can only be observed in patients undergoing IVF, and that the following description of RIF be adopted: 'RIF describes the scenario in which the transfer of embryos considered to be viable has failed to result in a positive pregnancy test sufficiently often in a specific patient to warrant consideration of further investigations and/or interventions'. It was agreed that the recommended threshold for the cumulative predicted chance of implantation to identify RIF for the purposes of initiating further investigation is 60%. When a couple have not had a successful implantation by a certain number of embryo transfers and the cumulative predicted chance of implantation associated with that number is greater than 60%, then they should be counselled on further investigation and/or treatment options. This term defines clinical RIF for which further actions should be considered. Nineteen recommendations were formulated on investigations when RIF is suspected, and 13 on interventions. Recommendations were c
研究问题:如何定义和处理接受抗逆转录病毒治疗的患者的复发性植入失败(RIF) ?概要回答:这是第一份ESHRE良好做法建议文件，提供了RIF的定义，并就如何调查原因和促成因素以及如何提高怀孕机会提出了建议。已知情况:RIF是抗逆转录病毒治疗诊所面临的一个挑战，在临床实践中提供和应用了大量的调查和干预措施，往往没有生物学依据或没有明确的益处证据。研究设计规模持续时间:本文档是根据ESHRE良好实践建议的预定义方法开发的。建议得到文献数据(如果有的话)、先前发表的RIF临床实践调查结果和工作组专业知识的支持。在PubMed和Cochrane上进行了文献检索，重点是“复发性生殖失败”、“复发性植入失败”和“重复植入失败”。参与者/材料设置方法:ESHRE复发性着床失败工作组包括8名成员，分别代表ESHRE着床与早孕、生殖内分泌学和胚胎学特别兴趣小组，由一名独立主席和一名统计学专家担任。临床实践的建议是根据工作组的专家意见制定的，同时考虑到已发表的数据和临床实践中摄取的调查结果。文件草案随后向ESHRE成员开放，供在线同行评审，并根据收到的意见进行了修订。主要结果和偶然性的作用:工作组建议将RIF视为ART的次要现象，因为它只能在接受体外受精的患者中观察到，并采用以下对RIF的描述:“RIF描述的情况是，被认为可行的胚胎移植未能在特定患者中经常导致妊娠试验阳性，因此需要考虑进一步调查和/或干预。”大家一致认为，为确定RIF而启动进一步研究的累积预测着床机会的推荐阈值为60%。如果一对夫妇没有通过一定数量的胚胎移植成功着床，并且与该数量相关的累计预测着床机会大于60%，则应建议他们进行进一步的调查和/或治疗选择。该术语定义了临床RIF，应考虑采取进一步措施。就怀疑发生RIF时的调查制定了19项建议，就干预措施制定了13项建议。根据调查/干预措施是建议(绿色)、考虑(橙色)还是不建议(即不定期提供)，对建议进行了颜色编码。局限性:在等待进一步研究和试验结果的同时，ESHRE复发性植入失败工作组建议根据患者或夫妇的成功植入机会来确定RIF，并将调查和治疗限制在那些有明确理由和数据表明其可能受益的研究和治疗。研究结果的更广泛含义:本文不仅提供了良好的实践建议，而且还强调了需要进一步研究的调查和干预措施。这项研究如果进行得好，将是RIF临床管理取得进展的关键。研究经费/竞争利益:该项目的会议和技术支持由ESHRE资助。N.M.从ArtPRED(荷兰)和Freya Biosciences(丹麦)申报咨询费;Gedeon Richter、Merck、Abbott和IBSA的讲座酬金;作为Verso Biosense的联合创始人他是生殖生物医学在线(RBMO)的联合主编。D.C.宣布成为《人类生殖更新》的副主编，并宣布获得默克、奥加农、IBSA和Fairtility的讲座荣誉;支持参加库珀外科公司，富士欧文科学公司的会议。G.G.声明他或他的机构在研究、讲座、研讨会、顾问角色或来自Ferring、Merck、Gedeon-Richter、PregLem、Abbott、Vifor、Organon、MSD、Coopersurgical、ObsEVA和repdwissen的旅行方面获得了财政或非财政支持。他是Journal Archives of Obstetrics and Gynecology and Reproductive biomedine Online的编辑，也是Journal Gynäkologische Endokrinologie的主编。他参与了国家和国际层面的指导方针制定和质量控制。G.L.宣称他或他的机构收到了默克、费灵、Vianex/Organon和默沙东的讲座酬金。 他是《人类生殖更新》的副主编，ESHRE生殖内分泌学特别兴趣小组的前任协调员，并参与了ESHRE和国家生育当局的指南制定小组。D.J.M.宣布成为《人类生殖开放》的副主编和《生殖生物医学在线》的统计顾问。B.T.宣布成为Reprognostics的股东，她或她的机构在研究、临床试验、讲座、研讨会、咨询角色或参加来自Ferring、MSD、Exeltis、默克雪兰诺、拜耳、Teva、Theramex和Novartis、Astropharm、Ferring的会议方面获得财务或非财务支持。其他作者没有什么可透露的。免责声明:本良好规范建议(GPR)文件代表了ESHRE的观点，是相关ESHRE利益相关者之间共识的结果，并以准备时可用的科学证据为基础。ESHRE GPRs应用于信息和教育目的。它们不应被解释为制定护理标准，或被视为包括所有适当的护理方法，或排除其他合理指导以获得相同结果的护理方法。它们不能取代对每个个体的临床判断的应用，或根据地点和设施类型的变化。此外，ESHRE gpr并不构成或暗示ESHRE认可或支持任何包含的技术。
{"title":"ESHRE good practice recommendations on recurrent implantation failure.","authors":"D Cimadomo, M J de Los Santos, G Griesinger, G Lainas, N Le Clef, D J McLernon, D Montjean, B Toth, N Vermeulen, N Macklon","doi":"10.1093/hropen/hoad023","DOIUrl":"https://doi.org/10.1093/hropen/hoad023","url":null,"abstract":"<p><strong>Study question: </strong>How should recurrent implantation failure (RIF) in patients undergoing ART be defined and managed?</p><p><strong>Summary answer: </strong>This is the first ESHRE good practice recommendations paper providing a definition for RIF together with recommendations on how to investigate causes and contributing factors, and how to improve the chances of a pregnancy.</p><p><strong>What is known already: </strong>RIF is a challenge in the ART clinic, with a multitude of investigations and interventions offered and applied in clinical practice, often without biological rationale or with unequivocal evidence of benefit.</p><p><strong>Study design size duration: </strong>This document was developed according to a predefined methodology for ESHRE good practice recommendations. Recommendations are supported by data from the literature, if available, and the results of a previously published survey on clinical practice in RIF and the expertise of the working group. A literature search was performed in PubMed and Cochrane focussing on 'recurrent reproductive failure', 'recurrent implantation failure', and 'repeated implantation failure'.</p><p><strong>Participants/materials setting methods: </strong>The ESHRE Working Group on Recurrent Implantation Failure included eight members representing the ESHRE Special Interest Groups for Implantation and Early Pregnancy, Reproductive Endocrinology, and Embryology, with an independent chair and an expert in statistics. The recommendations for clinical practice were formulated based on the expert opinion of the working group, while taking into consideration the published data and results of the survey on uptake in clinical practice. The draft document was then open to ESHRE members for online peer review and was revised in light of the comments received.</p><p><strong>Main results and the role of chance: </strong>The working group recommends considering RIF as a secondary phenomenon of ART, as it can only be observed in patients undergoing IVF, and that the following description of RIF be adopted: 'RIF describes the scenario in which the transfer of embryos considered to be viable has failed to result in a positive pregnancy test sufficiently often in a specific patient to warrant consideration of further investigations and/or interventions'. It was agreed that the recommended threshold for the cumulative predicted chance of implantation to identify RIF for the purposes of initiating further investigation is 60%. When a couple have not had a successful implantation by a certain number of embryo transfers and the cumulative predicted chance of implantation associated with that number is greater than 60%, then they should be counselled on further investigation and/or treatment options. This term defines clinical RIF for which further actions should be considered. Nineteen recommendations were formulated on investigations when RIF is suspected, and 13 on interventions. Recommendations were c","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 3","pages":"hoad023"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5f/b8/hoad023.PMC10270320.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9715806","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alessandra Chinè, Marco Reschini, Gianfranco Fornelli, Ludovica Basili, Andrea Busnelli, Paola Viganò, Ludovico Muzii, Edgardo Somigliana
<p><strong>Study question: </strong>Do low levels of anti-Müllerian hormone (AMH) or antral follicle count (AFC) properly predict miscarriage in young women conceiving with ART?</p><p><strong>Summary answer: </strong>Low ovarian reserve, as indicated by AMH or AFC, is not associated with miscarriage in young women conceiving with ART.</p><p><strong>What is known already: </strong>Presently, the impact of low ovarian reserve on the risk of miscarriage remains controversial. Some studies have reported an association between serum AMH levels and AFC and miscarriage, but others have failed to confirm these findings. The main limitation that undermines the reliability and consistency of the results is the confounding effect of female age. Indeed, after 35 years of age, on the one hand, the risk of miscarriage starts increasing because of impaired oocyte quality while, on the other, the physiological decline in AMH and AFC levels continues, thus hampering the possibility to properly explore the real effects of reduced ovarian reserve. Indeed, the two processes, i.e. the gradual loss of resting primordial follicles and the loss of oocyte quality, progress in parallel. In other words, the older the woman becomes, the higher is the risk of miscarriage, but one cannot distinguish between the effects of biological aging on oocyte quality and those mediated by a lower ovarian reserve.</p><p><strong>Study design size duration: </strong>The present retrospective monocentric cohort study was carried out at Fondazione IRCSS Ca Granda Ospedale Maggiore Policlinico, Milan. All women referred to the ART Unit between 2014 and 2021 and who underwent either conventional IVF (c-IVF), ICSI, or IUI were reviewed. Only women younger than 35 were eligible because, up to this age, the risk of miscarriage is steady and not strictly related to age.</p><p><strong>Participants/materials setting methods: </strong>Women younger than 35 who achieved a singleton clinical pregnancy with c-IVF, ICSI, or IUI were selected. Women with patent causes of recurrent miscarriage were excluded, as well as those undergoing pregnancy termination for fetal or medical causes. Women who did and did not have a pregnancy loss before 20 weeks' gestation were compared. Detailed information was obtained from charts of the consulting patients. ART procedures were performed according to the standardized policy of our Unit. All women underwent serum AMH measurement and a transvaginal assessment of AFC prior to initiation of treatment. AMH levels were measured by a commercially available ELISA assay. To assess AFC, all identifiable antral follicles 2-10 mm in diameter at ultrasound were recorded. The primary outcome was the risk of miscarriage for women with serum AMH levels below 5 pmol/l.</p><p><strong>Main results and the role of chance: </strong>There were 538 women were included, of whom 92 (17%) had a miscarriage. The areas under the ROC curves for prediction of miscarriage based on AMH levels and AF
{"title":"Low ovarian reserve and risk of miscarriage in pregnancies derived from assisted reproductive technology.","authors":"Alessandra Chinè, Marco Reschini, Gianfranco Fornelli, Ludovica Basili, Andrea Busnelli, Paola Viganò, Ludovico Muzii, Edgardo Somigliana","doi":"10.1093/hropen/hoad026","DOIUrl":"https://doi.org/10.1093/hropen/hoad026","url":null,"abstract":"<p><strong>Study question: </strong>Do low levels of anti-Müllerian hormone (AMH) or antral follicle count (AFC) properly predict miscarriage in young women conceiving with ART?</p><p><strong>Summary answer: </strong>Low ovarian reserve, as indicated by AMH or AFC, is not associated with miscarriage in young women conceiving with ART.</p><p><strong>What is known already: </strong>Presently, the impact of low ovarian reserve on the risk of miscarriage remains controversial. Some studies have reported an association between serum AMH levels and AFC and miscarriage, but others have failed to confirm these findings. The main limitation that undermines the reliability and consistency of the results is the confounding effect of female age. Indeed, after 35 years of age, on the one hand, the risk of miscarriage starts increasing because of impaired oocyte quality while, on the other, the physiological decline in AMH and AFC levels continues, thus hampering the possibility to properly explore the real effects of reduced ovarian reserve. Indeed, the two processes, i.e. the gradual loss of resting primordial follicles and the loss of oocyte quality, progress in parallel. In other words, the older the woman becomes, the higher is the risk of miscarriage, but one cannot distinguish between the effects of biological aging on oocyte quality and those mediated by a lower ovarian reserve.</p><p><strong>Study design size duration: </strong>The present retrospective monocentric cohort study was carried out at Fondazione IRCSS Ca Granda Ospedale Maggiore Policlinico, Milan. All women referred to the ART Unit between 2014 and 2021 and who underwent either conventional IVF (c-IVF), ICSI, or IUI were reviewed. Only women younger than 35 were eligible because, up to this age, the risk of miscarriage is steady and not strictly related to age.</p><p><strong>Participants/materials setting methods: </strong>Women younger than 35 who achieved a singleton clinical pregnancy with c-IVF, ICSI, or IUI were selected. Women with patent causes of recurrent miscarriage were excluded, as well as those undergoing pregnancy termination for fetal or medical causes. Women who did and did not have a pregnancy loss before 20 weeks' gestation were compared. Detailed information was obtained from charts of the consulting patients. ART procedures were performed according to the standardized policy of our Unit. All women underwent serum AMH measurement and a transvaginal assessment of AFC prior to initiation of treatment. AMH levels were measured by a commercially available ELISA assay. To assess AFC, all identifiable antral follicles 2-10 mm in diameter at ultrasound were recorded. The primary outcome was the risk of miscarriage for women with serum AMH levels below 5 pmol/l.</p><p><strong>Main results and the role of chance: </strong>There were 538 women were included, of whom 92 (17%) had a miscarriage. The areas under the ROC curves for prediction of miscarriage based on AMH levels and AF","PeriodicalId":73264,"journal":{"name":"Human reproduction open","volume":"2023 3","pages":"hoad026"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/83/c4/hoad026.PMC10243845.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9971625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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