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The Donor Conception Identity Questionnaire: associations with mental health and searching for and finding donor connections 捐赠者受孕身份问卷:与心理健康和寻找捐赠者关系的关联。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.08.331
Vasanti Jadva Ph.D. , Catherine Jones Ph.D. , Sophie Zadeh Ph.D.
<div><h3>Objective</h3><div>To understand how the Donor Conception Identity Questionnaire (DCIQ) correlates with mental health and explore differences in the DCIQ between donor conceived people who were actively searching for donor connections to those who were not and those who had found their donor connections to those who had not.</div></div><div><h3>Design</h3><div>Cross-sectional survey.</div></div><div><h3>Subjects</h3><div>A total of 88 donor conceived adults ranging in age from 18 to 70 (mean, 34.27 years; median, 31 years). A total of 39 participants were actively searching for their donor connections, and 49 were not.</div></div><div><h3>Exposure</h3><div>Donor conception identity was measured using a questionnaire and scores were correlated with existing measures of mental health.</div></div><div><h3>Main Outcome Measure(s)</h3><div>Participants completed the DCIQ and measures of well-being, satisfaction with life, identity, pride, and stigma.</div></div><div><h3>Result(s)</h3><div>Factor analysis of items from the DCIQ identified four domains: concern and preoccupation; internalized stigma; pride and acceptance; and openness and understanding. The identified factors correlated with scales of psychological and social well-being. Active searchers scored higher than non-active searchers on “concern and preoccupation” and “internalized stigma”. Donor conceived individuals who had found their donor connections scored lower on “internalized stigma” and higher on “openness and understanding” compared with those who had not found their donor connections.</div></div><div><h3>Conclusion(s)</h3><div>The findings of the present study show that scores on the DCIQ correlate with existing measures of psychological and social well-being. Furthermore, donor conceived individuals searching for their donor connections differ from those not actively searching on key domains of the DCIQ. Implications for future avenues of study and support for donor conceived people are discussed.</div></div><div><div>Cuestionario de Identidad de Concepción por donante: asociaciones con la salud mental y la búsqueda y el encuentro de conexiones con donantes</div></div><div><h3>Objetivo</h3><div>comprender cómo el Cuestionario de Identidad de Concepción por Donante (DCIQ) se correlaciona con la salud mental y explorar las diferencias en el DCIQ entre las personas concebidas por donación que estaban buscando activamente conexiones con donantes y las que no, así como aquellas que habían encontrado sus conexiones con donantes y las que no.</div></div><div><h3>Diseño</h3><div>una encuesta transversal.</div></div><div><h3>Lugar</h3><div>encuesta realizada en línea en el Reino Unido.</div></div><div><h3>Paciente(s)</h3><div>Un total de 88 adultos concebidos por donación, con edades comprendidas entre los 18 y los 70 años (media, 34.27 años; mediana, 31 años). Un total de 39 pacientes estaban activamente buscado sus conexiones con donantes y 49, no.</div></div><div><h3>Intervenci
目的了解捐献者受孕身份问卷(DCIQ)与心理健康的相关性,探讨积极寻找捐献者联系的受孕者与未找到捐献者联系的受孕者,以及已找到捐献者联系的受孕者与未找到捐献者联系的受孕者在DCIQ上的差异:设计:横断面调查:88名年龄从18岁到70岁不等(平均年龄=34.27岁,中位数=31岁)的捐赠受孕成年人。39名参与者正在积极寻找与捐献者的联系,49名没有:主要结果测量:主要结果测量:参与者填写了捐献者受孕问卷,并对幸福感、生活满意度、身份认同感、自豪感和耻辱感进行了测量:对 DCIQ 中的项目进行因子分析,确定了四个领域:1.1.关注和担忧;2.内化成见;3.自豪和接受;4.开放和理解。开放和理解。确定的因素与心理和社会福祉量表相关。积极寻找者比不积极寻找者在 "关注和担忧"(F(1, 79) = 7.543, p = .007)和 "内化耻辱"(F(1, 79) = 4.355, p = .040)方面得分更高。与未找到捐献者关系的受孕者相比,找到捐献者关系的受孕者在 "内化耻辱感 "方面的得分较低,F(1,79)= 7.071,p =.009,在 "开放性和理解 "方面得分较高(F(1,79)= 6.083,p = 0.016):本研究的结果表明,DCIQ 的核心内容与现有的心理和社会福利衡量标准相关。此外,正在寻找捐献者关系的受孕者与未积极寻找的受孕者在 DCIQ 的关键领域上存在差异。本文讨论了未来的研究方向以及对受孕捐献者提供支持的意义。
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引用次数: 0
Follitropin delta: is further evidence needed? δ型促甲状腺激素:是否需要进一步的证据?
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.08.353
Stefano Palomba M.D., Donatella Caserta M.D.
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引用次数: 0
Morphological changes of endometriomas during pregnancy and after delivery detected using ultrasound 用超声波检测妊娠期和产后子宫内膜异位症的形态变化。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.08.355
Sofie Orlov M.D. , Povilas Sladkevicius M.D., Ph.D. , Isis Rivano Eckerdal M.D. , Ligita Jokubkiene M.D., Ph.D.
<div><h3>Objective</h3><div>To assess changes in morphology and size of endometriomas during pregnancy and after delivery.</div></div><div><h3>Design</h3><div>This was a prospective observational cohort study performed during 2013–2024 at a tertiary care center (Ultrasound Unit, Department of Obstetrics and Gynecology, Skane University Hospital, Malmo, Sweden). Women were offered repeated ultrasound examinations every month during pregnancy and thereafter at 3 and 12 months after delivery. Ultrasound examinations were performed either transvaginally or transabdominally depending on the gestational week and assessability of the ovaries.</div></div><div><h3>Subjects</h3><div>Pregnant women with an ovarian cyst suggestive of endometrioma based on subjective assessment were eligible and those with the pregnancy that continued beyond gestational age of 22 weeks were included. In total, 57 women were included.</div></div><div><h3>Exposure</h3><div>Pregnancy.</div></div><div><h3>Main Outcome Measure(s)</h3><div>Changes in morphology (cyst type, cyst content, and signs of decidualization) and size of the endometrioma and the largest solid component were assessed during follow-up ultrasound examinations.</div></div><div><h3>Result(s)</h3><div>During pregnancy, endometriomas changed in morphology in 42/57 women (74%; 95% confidence interval [CI], 60–84) and decreased in size in 42/57 women (74%; 95% CI, 60–84). Decidualization of endometrioma was observed in 33/57 women (58%; 95% CI, 44–71) and was detected first time at gestational age of 17 weeks (median, interquartile range, 15–22; range, 6–29). The size of endometriomas decreased although the size of solid components increased from gestational age of 22<sup>+0</sup> weeks. Signs of decidualization disappeared after delivery.</div></div><div><h3>Conclusion(s)</h3><div>Three out of four endometriomas undergo morphological changes during pregnancy. Decidualized endometrioma may mimic borderline malignancy, however, changes regress after delivery. Knowing the natural behavior of endometriomas during pregnancy is crucial to reducing the risk of misclassification of endometriomas as malignant masses. Follow-up ultrasound examination after delivery helps to reassure the benign nature of the cyst.</div></div><div><div>Cambios morfológicos de los endometriomas durante el embarazo y después del parto detectados mediante ecografía.</div></div><div><h3>Objetivo</h3><div>Evaluar los cambios en la morfología y el tamaño de los endometriomas durante el embarazo y después del parto.</div></div><div><h3>Diseño</h3><div>Estudio observacional prospectivo de cohorte realizado entre 2013 y 2024 en un centro de atención terciaria (Unidad de Ultrasonido, Departamento de Obstetricia y Ginecología, Hospital Universitario de Skane, Malmö, Suecia). A las mujeres se les ofrecieron exámenes repetidos de ultrasonido cada mes durante el embarazo y posteriormente a los 3 y 12 meses tras el parto. Las ecografías se realizaron por vía
目的: 评估妊娠期和产后子宫内膜异位症的形态和大小变化:评估妊娠期和产后子宫内膜异位症的形态和大小变化:这是一项前瞻性观察性队列研究,2013-2024 年期间在一家三级医疗中心(瑞典马尔默市斯卡内大学医院妇产科超声室)进行。妇女在怀孕期间每月接受一次重复超声波检查,之后在分娩后 3 个月和 12 个月接受检查。超声波检查根据孕周和卵巢的可评估性经阴道或经腹部进行:受试者:根据主观评估,卵巢囊肿提示子宫内膜异位症的孕妇符合条件,妊娠超过 22 周的孕妇也包括在内。共纳入 57 名妇女:主要结果测量:主要结果测量:在随访超声检查中评估子宫内膜异位症的形态变化(囊肿类型、囊肿内容和蜕膜化迹象)、子宫内膜异位症的大小以及最大的实性成分:怀孕期间,42/57 名妇女的子宫内膜异位瘤形态发生了变化(74%,95% CI 60 - 84),42/57 名妇女的子宫内膜异位瘤大小减小(74%,95% CI 60 - 84)。有 33/57 名妇女(58%,95% CI 44 - 71)观察到子宫内膜异位症蜕膜化,首次发现时孕龄为 17 周(中位数,IQR 15 - 22,范围 6 - 29)。从孕 22+0 周开始,子宫内膜瘤的大小减小,而实性成分的大小增大。蜕膜化迹象在分娩后消失:结论:四分之三的子宫内膜瘤在妊娠期间会发生形态变化。蜕膜化的子宫内膜异位症可能与边缘恶性肿瘤相似,但分娩后变化会消失。了解妊娠期子宫内膜异位症的自然表现对于降低子宫内膜异位症被误诊为恶性肿瘤的风险至关重要。分娩后的随访超声检查有助于确定囊肿的良性性质。
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引用次数: 0
Pulsatile gonadotropin-releasing hormone therapy: comparison of efficacy between functional hypothalamic amenorrhea and congenital hypogonadotropic hypogonadism 脉冲式 GnRH 治疗:功能性下丘脑性闭经与先天性性腺功能减退症的疗效比较。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.08.354
Hortense Everaere M.D. , Virginie Simon M.D. , Anne Bachelot M.D., Ph.D. , Maxime Leroy B.S. , Christine Decanter M.D. , Didier Dewailly M.D. , Sophie Catteau-Jonard M.D., Ph.D. , Geoffroy Robin M.D.
<div><h3>Objective</h3><div>To compare the ongoing pregnancy rate per initiated cycle between patients with functional hypothalamic amenorrhea (FHA) and patients with congenital hypogonadotropic hypogonadism (CHH) treated with pulsatile gonadotropin-releasing hormone (GnRH) administration.</div></div><div><h3>Design</h3><div>Retrospective monocentric cohort study conducted at the University Hospital of Lille from 2004 to 2022.</div></div><div><h3>Subjects</h3><div>A total of 141 patients diagnosed with central suprapituitary amenorrhea during infertility evaluation and subsequently treated with pulsatile GnRH therapy. 111 and 30 patients were diagnosed with FHA or CHH, respectively.</div></div><div><h3>Exposure</h3><div>Pulsatile GnRH administration.</div></div><div><h3>Main Outcome Measure(s)</h3><div>Ongoing pregnancy rate per initiated cycle.</div></div><div><h3>Result(s)</h3><div>Ongoing pregnancy rates per initiated cycle were comparable between groups: 21.5% in the FHA group vs. 22% in the CHH group. Comparison of baseline characteristics showed a more pronounced follicle-stimulating hormone (FSH) deficiency in patients with CHH than in those with FHA: 2.55 (0.6–4.92) vs. 4.80 (3.90–5.70) UI/L. Within the CHH group, basal FSH level was positively associated with the occurrence of ongoing pregnancies (odds ratio, 1.57; 95% confidence interval, 1.11–2.22). In the CHH group, the duration of treatment was higher than in the FHA group: 23.59 (± 8.02) vs. 18.16 (± 7.66) days.</div></div><div><h3>Conclusion(s)</h3><div>The baseline FSH level is lower in patients with CHH than in patients with FHA. The lower the FSH, the lower the chance of pregnancy in patients with CHH. These patients also require more days of GnRH administration. However, the rate of ongoing pregnancies is comparable between the two groups.</div></div><div><div>Terapia hormonal pulsátil liberadora de gonadotropina: Comparación de la eficacia entre la amenorrea hipotalámica funcional y el hipogonadismo hipogonadotrópico congénito</div></div><div><h3>Objetivo</h3><div>Comparar la tasa de embarazo en curso por ciclo iniciado entre pacientes con amenorrea hipotalámica funcional (AHF) y pacientes con hipogonadismo hipogonadotrópico congénito (HHC) tratadas con administración pulsátil de hormona liberadora de gonadotropina (GnRH).</div></div><div><h3>Diseño</h3><div>Estudio de cohorte retrospectivo monocéntrico llevado a cabo en la Universidad Hospital de Lille desde el 2004 al 2022.</div></div><div><h3>Escenario</h3><div>Universidad Hospital de Lille, Departamento de Ginecología Endocrina.</div></div><div><h3>Paciente(s)</h3><div>Un total de 141 pacientes diagnosticas con amenorrea suprapituitaria central durante la evaluación por infertilidad y subsecuentemente tratadas con terapía pulsátil de GnRH. 111 y 30 pacientes fueron diagnosticas con AHF y HHC, respectivamente.</div></div><div><h3>Intervención(es)</h3><div>Administración pulsátil de GnRH.</div></div><div><h3>Medida de result
目的比较功能性下丘脑性闭经患者和先天性性腺功能减退症患者接受脉冲式GnRH治疗后每个启动周期的持续妊娠率:2004年至2022年在里尔大学医院进行的回顾性单中心队列研究:141名患者在不孕症评估中被诊断为中枢性垂体上叶闭经,随后接受脉冲式GnRH治疗。111名和30名患者分别被诊断为功能性下丘脑性闭经或先天性性腺功能减退症:主要结局指标:每个启动周期的持续妊娠率:各组间每个启动周期的持续妊娠率相当:功能性下丘脑性闭经组为21.5%,先天性性腺功能减退症组为22%;P=0.537。基线特征比较显示,先天性促性腺激素低下患者的FSH缺乏比功能性下丘脑性闭经患者更明显:2.55 [0.6 - 4.92] UI/L对4.80 [3.90 - 5.70] UI/L;p结论:先天性促性腺激素低下患者的FSH缺乏比功能性下丘脑性闭经患者更明显:2.55 [0.6 - 4.92] UI/L对4.80 [3.90 - 5.70] UI/L:先天性性腺功能减退症患者的基线 FSH 低于功能性下丘脑闭经患者。FSH越低,先天性性腺功能减退症患者怀孕的几率就越低。这些患者也需要更多天的 GnRH 给药。不过,两组患者的持续妊娠率相当。
{"title":"Pulsatile gonadotropin-releasing hormone therapy: comparison of efficacy between functional hypothalamic amenorrhea and congenital hypogonadotropic hypogonadism","authors":"Hortense Everaere M.D. ,&nbsp;Virginie Simon M.D. ,&nbsp;Anne Bachelot M.D., Ph.D. ,&nbsp;Maxime Leroy B.S. ,&nbsp;Christine Decanter M.D. ,&nbsp;Didier Dewailly M.D. ,&nbsp;Sophie Catteau-Jonard M.D., Ph.D. ,&nbsp;Geoffroy Robin M.D.","doi":"10.1016/j.fertnstert.2024.08.354","DOIUrl":"10.1016/j.fertnstert.2024.08.354","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;To compare the ongoing pregnancy rate per initiated cycle between patients with functional hypothalamic amenorrhea (FHA) and patients with congenital hypogonadotropic hypogonadism (CHH) treated with pulsatile gonadotropin-releasing hormone (GnRH) administration.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Design&lt;/h3&gt;&lt;div&gt;Retrospective monocentric cohort study conducted at the University Hospital of Lille from 2004 to 2022.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Subjects&lt;/h3&gt;&lt;div&gt;A total of 141 patients diagnosed with central suprapituitary amenorrhea during infertility evaluation and subsequently treated with pulsatile GnRH therapy. 111 and 30 patients were diagnosed with FHA or CHH, respectively.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Exposure&lt;/h3&gt;&lt;div&gt;Pulsatile GnRH administration.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Main Outcome Measure(s)&lt;/h3&gt;&lt;div&gt;Ongoing pregnancy rate per initiated cycle.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Result(s)&lt;/h3&gt;&lt;div&gt;Ongoing pregnancy rates per initiated cycle were comparable between groups: 21.5% in the FHA group vs. 22% in the CHH group. Comparison of baseline characteristics showed a more pronounced follicle-stimulating hormone (FSH) deficiency in patients with CHH than in those with FHA: 2.55 (0.6–4.92) vs. 4.80 (3.90–5.70) UI/L. Within the CHH group, basal FSH level was positively associated with the occurrence of ongoing pregnancies (odds ratio, 1.57; 95% confidence interval, 1.11–2.22). In the CHH group, the duration of treatment was higher than in the FHA group: 23.59 (± 8.02) vs. 18.16 (± 7.66) days.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion(s)&lt;/h3&gt;&lt;div&gt;The baseline FSH level is lower in patients with CHH than in patients with FHA. The lower the FSH, the lower the chance of pregnancy in patients with CHH. These patients also require more days of GnRH administration. However, the rate of ongoing pregnancies is comparable between the two groups.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;Terapia hormonal pulsátil liberadora de gonadotropina: Comparación de la eficacia entre la amenorrea hipotalámica funcional y el hipogonadismo hipogonadotrópico congénito&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objetivo&lt;/h3&gt;&lt;div&gt;Comparar la tasa de embarazo en curso por ciclo iniciado entre pacientes con amenorrea hipotalámica funcional (AHF) y pacientes con hipogonadismo hipogonadotrópico congénito (HHC) tratadas con administración pulsátil de hormona liberadora de gonadotropina (GnRH).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Diseño&lt;/h3&gt;&lt;div&gt;Estudio de cohorte retrospectivo monocéntrico llevado a cabo en la Universidad Hospital de Lille desde el 2004 al 2022.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Escenario&lt;/h3&gt;&lt;div&gt;Universidad Hospital de Lille, Departamento de Ginecología Endocrina.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Paciente(s)&lt;/h3&gt;&lt;div&gt;Un total de 141 pacientes diagnosticas con amenorrea suprapituitaria central durante la evaluación por infertilidad y subsecuentemente tratadas con terapía pulsátil de GnRH. 111 y 30 pacientes fueron diagnosticas con AHF y HHC, respectivamente.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Intervención(es)&lt;/h3&gt;&lt;div&gt;Administración pulsátil de GnRH.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Medida de result","PeriodicalId":12275,"journal":{"name":"Fertility and sterility","volume":"123 2","pages":"Pages 270-279"},"PeriodicalIF":6.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142132276","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From breast cancer to fertility outcomes: increasing understanding of urgent fertility preservation 从乳腺癌到生育结果:提高对紧急生育保护的认识。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.09.026
Shunshun Cao M.Sc. , Yangyang Hu M.Sc.
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引用次数: 0
Randomized, controlled, proof-of-concept trial of gefapixant for endometriosis-related pain 吉法匹克治疗子宫内膜异位症相关疼痛的随机对照概念验证试验。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.09.013
Felipe Arbelaez M.D. , Hee-Koung Joeng Ph.D. , Azher Hussain Ph.D. , Sheila Sunga Ph.D. , Yanfen Guan M.S. , Akshita Chawla Ph.D. , Francisco Carmona M.D. , Christopher Lines Ph.D. , Geraldine Mendizabal M.D.
<div><h3>Objective</h3><div>To evaluate the P2X3 receptor antagonist, gefapixant, for treating moderate-to-severe endometriosis-related pain.</div></div><div><h3>Design</h3><div>Randomized, double-blind, phase 2, and proof-of-concept trial.</div></div><div><h3>Subjects</h3><div>Premenopausal women age 18–49 years with moderate-to-severe endometriosis-related pain who were not using hormonal treatment.</div></div><div><h3>Intervention(s)</h3><div>Gefapixant (45-mg twice daily) or placebo over two menstrual cycles.</div></div><div><h3>Main outcome measure(s)</h3><div>Participants rated peak pelvic pain severity daily on a 0 (no pain) – 10 (extremely severe pain) scale. The primary endpoint was change from baseline in average daily peak pelvic pain severity during treatment cycle 2.</div></div><div><h3>Result(s)</h3><div>All 187 participants randomized (gefapixant, N = 94; placebo, N = 93) took ≥1 dose of investigational treatment and all but six in each treatment group completed the trial. The model-based least-squares mean reduction from baseline in average daily peak pelvic pain severity during treatment cycle 2 was –2.2 for gefapixant and –1.7 for placebo (difference, –0.5; 95% confidence interval, –1.01 to 0.03). In secondary analyses, the difference between gefapixant and placebo in peak pelvic pain severity reduction from baseline on menstrual days was –0.6 (95% confidence interval, –1.18 to –0.06) and –0.5 (95% confidence interval, –1.04 to 0.03) on nonmenstrual days. Taste-related adverse events were reported in 31.9% of participants for gefapixant vs. 4.3% for placebo. Pharmacokinetic assessments at months 1 and 2 clinic visits indicated that of the 94 participants in the gefapixant group, 39 had detectable levels of gefapixant in the blood for both assessments although 38 had no detectable levels for ≥1 assessment.</div></div><div><h3>Conclusion(s)</h3><div>Gefapixant (45-mg twice daily) was not shown to be superior to placebo in reducing endometriosis-related pain, although the results directionally favored gefapixant. This trial result should be considered inconclusive given possible issues with treatment compliance.</div></div><div><h3>Clinical Trial Registration Number</h3><div>NCT03654326.</div></div><div><div>Ensayo Aleatorizado, controlado, prueba de concepto de gefapixant para el dolor relacionado con la endometriosis</div></div><div><h3>Objetivo</h3><div>Evaluar el receptor antagonista del P2X3, gefapixant, para el tratamiento del dolor moderado a severo relacionado con la endometriosis.</div></div><div><h3>Diseño</h3><div>ensayo aleatorizado, doble ciego, de fase 2 y de prueba de concepto.</div></div><div><h3>Ámbito</h3><div>Pacientes ambulatorios en hospitales, centros médicos o sitios de investigación clínica.</div></div><div><h3>Paciente(s)</h3><div>Mujeres premenopáusicas de 18 a 49 años con dolor relacionado con la endometriosis de moderado a severo que no estaban usando tratamiento hormonal.</div></div><div><h3>Intervenció
目的评估 P2X3 受体拮抗剂吉法匹克生治疗中度至重度子宫内膜异位症相关疼痛的效果:随机、双盲、2 期、概念验证试验:干预措施:吉非那雄胺 45 毫克,每两周一次:主要结果测量:参与者每天对盆腔疼痛峰值的严重程度进行评分,评分标准为0(无痛)-10(极度疼痛)分级。主要终点是治疗周期 2 中平均每日盆腔疼痛峰值严重程度与基线相比的变化:所有 187 名随机参与者(吉非那雄胺 94 人,安慰剂 93 人)均服用了≥1 个剂量的研究治疗药物,除 6 人外,各治疗组均完成了试验。在治疗周期2期间,基于模型的最小二乘法计算得出的平均每日盆腔疼痛峰值从基线降低的平均值为:吉法必雄-2.2,安慰剂-1.7(差异=-0.5 [95%置信区间:-1.01,0.03],P=0.066)。在二次分析中,吉法匹克与安慰剂在月经日盆腔疼痛峰值严重程度从基线降低的差异为-0.6[95%置信区间:-1.18,-0.06],在非月经日为-0.5[95%置信区间:-1.04,0.03]。31.9%的参与者报告了与味觉相关的不良事件,而服用吉法匹克的参与者仅有4.3%。第1个月和第2个月门诊的药代动力学评估显示,在吉法匹克组中的94名参与者中,有39人在两次评估中都能检测到血液中的吉法匹克水平,而38人在≥1次评估中均未检测到吉法匹克水平:结论:在减轻子宫内膜异位症相关疼痛方面,每日两次、每次 45 毫克的吉法匹克并没有显示出优于安慰剂的效果,尽管试验结果倾向于吉法匹克。考虑到治疗依从性方面可能存在的问题,这一试验结果应视为不确定结果。(临床试验注册:NCT03654326)。
{"title":"Randomized, controlled, proof-of-concept trial of gefapixant for endometriosis-related pain","authors":"Felipe Arbelaez M.D. ,&nbsp;Hee-Koung Joeng Ph.D. ,&nbsp;Azher Hussain Ph.D. ,&nbsp;Sheila Sunga Ph.D. ,&nbsp;Yanfen Guan M.S. ,&nbsp;Akshita Chawla Ph.D. ,&nbsp;Francisco Carmona M.D. ,&nbsp;Christopher Lines Ph.D. ,&nbsp;Geraldine Mendizabal M.D.","doi":"10.1016/j.fertnstert.2024.09.013","DOIUrl":"10.1016/j.fertnstert.2024.09.013","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Objective&lt;/h3&gt;&lt;div&gt;To evaluate the P2X3 receptor antagonist, gefapixant, for treating moderate-to-severe endometriosis-related pain.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Design&lt;/h3&gt;&lt;div&gt;Randomized, double-blind, phase 2, and proof-of-concept trial.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Subjects&lt;/h3&gt;&lt;div&gt;Premenopausal women age 18–49 years with moderate-to-severe endometriosis-related pain who were not using hormonal treatment.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Intervention(s)&lt;/h3&gt;&lt;div&gt;Gefapixant (45-mg twice daily) or placebo over two menstrual cycles.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Main outcome measure(s)&lt;/h3&gt;&lt;div&gt;Participants rated peak pelvic pain severity daily on a 0 (no pain) – 10 (extremely severe pain) scale. The primary endpoint was change from baseline in average daily peak pelvic pain severity during treatment cycle 2.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Result(s)&lt;/h3&gt;&lt;div&gt;All 187 participants randomized (gefapixant, N = 94; placebo, N = 93) took ≥1 dose of investigational treatment and all but six in each treatment group completed the trial. The model-based least-squares mean reduction from baseline in average daily peak pelvic pain severity during treatment cycle 2 was –2.2 for gefapixant and –1.7 for placebo (difference, –0.5; 95% confidence interval, –1.01 to 0.03). In secondary analyses, the difference between gefapixant and placebo in peak pelvic pain severity reduction from baseline on menstrual days was –0.6 (95% confidence interval, –1.18 to –0.06) and –0.5 (95% confidence interval, –1.04 to 0.03) on nonmenstrual days. Taste-related adverse events were reported in 31.9% of participants for gefapixant vs. 4.3% for placebo. Pharmacokinetic assessments at months 1 and 2 clinic visits indicated that of the 94 participants in the gefapixant group, 39 had detectable levels of gefapixant in the blood for both assessments although 38 had no detectable levels for ≥1 assessment.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusion(s)&lt;/h3&gt;&lt;div&gt;Gefapixant (45-mg twice daily) was not shown to be superior to placebo in reducing endometriosis-related pain, although the results directionally favored gefapixant. This trial result should be considered inconclusive given possible issues with treatment compliance.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Clinical Trial Registration Number&lt;/h3&gt;&lt;div&gt;NCT03654326.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;Ensayo Aleatorizado, controlado, prueba de concepto de gefapixant para el dolor relacionado con la endometriosis&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Objetivo&lt;/h3&gt;&lt;div&gt;Evaluar el receptor antagonista del P2X3, gefapixant, para el tratamiento del dolor moderado a severo relacionado con la endometriosis.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Diseño&lt;/h3&gt;&lt;div&gt;ensayo aleatorizado, doble ciego, de fase 2 y de prueba de concepto.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Ámbito&lt;/h3&gt;&lt;div&gt;Pacientes ambulatorios en hospitales, centros médicos o sitios de investigación clínica.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Paciente(s)&lt;/h3&gt;&lt;div&gt;Mujeres premenopáusicas de 18 a 49 años con dolor relacionado con la endometriosis de moderado a severo que no estaban usando tratamiento hormonal.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Intervenció","PeriodicalId":12275,"journal":{"name":"Fertility and sterility","volume":"123 2","pages":"Pages 280-288"},"PeriodicalIF":6.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The additional value of ultrasound markers in the diagnosis of polycystic ovary syndrome 超声标记在诊断多囊卵巢综合症中的附加价值。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.08.342
Kim van der Ham M.D. , Federica Barbagallo M.D. , Emiliya van Schilfgaarde B.Sc. , Marla E. Lujan Ph.D. , Joop S.E. Laven Ph.D. , Yvonne V. Louwers Ph.D.
<div><h3>Objective</h3><div>To study the value of current definitions for follicle number per ovary and ovarian volume in the diagnosis of polycystic ovary syndrome (PCOS).</div></div><div><h3>Design</h3><div>Cross-sectional study.</div></div><div><h3>Subjects</h3><div>Women diagnosed with PCOS after standardized screening were eligible for inclusion in the PCOS group. Women without PCOS who underwent the same screening, had regular menstrual cycles, normal hormonal values, and no other endocrine pathology were eligible for inclusion.</div></div><div><h3>Exposure</h3><div>Not applicable.</div></div><div><h3>Main Outcome Measure(s)</h3><div>Follicle number per ovary and ovarian volume in women with PCOS, stratified by age. Linear regression models to investigate the influence of body mass index (BMI) on follicle number per ovary and ovarian volume. Differences in follicle number per ovary and ovarian volume between the PCOS phenotypes and the additional value of ovarian volume compared with follicle number per ovary.</div></div><div><h3>Result(s)</h3><div>A total of 2,492 women (16–50 years) with PCOS and 152 women without PCOS were included. Most women with PCOS up to age of 35 exhibit a follicle number per ovary ≥20 (87.8%–100%) (using an ultrasound transducer ≥8 MHz) or ≥12 (95.1%–98.6%) (using a transducer <8 MHz), followed by a decline in follicle number per ovary >35 years. Median ovarian volume was below the 10 mL cutoff in every age group, for both ultrasound transducers. Follicle number per ovary and ovarian volume were higher in women with PCOS compared with women without PCOS in every age category. In our cohort, 13/2,297 women with PCOS (0.6%) would not have received the diagnosis if ovarian volume was not considered a marker for polycystic ovarian morphology. For both ultrasound transducers, women with phenotype A (ovulatory dysfunction + hyperandrogenism + polycystic ovarian morphology) exhibited the highest follicle number per ovary and ovarian volume, followed by phenotype D (ovulatory dysfunction + polycystic ovarian morphology), then phenotype C (hyperandrogenism + polycystic ovarian morphology), and then phenotype B (ovulatory dysfunction + hyperandrogenism). No clinically significant correlation between BMI and follicle number per ovary or ovarian volume was observed.</div></div><div><h3>Conclusion(s)</h3><div>Criteria to define follicle number per ovary should be established per age category, as follicle number per ovary decreases with age. Ovarian volume shows a less clear decline with age and has a lower discriminative power, and therefore could be excluded from the diagnostic criteria. Follicle number per ovary does not need to be stratified by BMI.</div></div><div><div>El valor adicional de los marcadores ecográficos en el diagnóstico del síndrome de ovario poliquístico</div></div><div><h3>Objetivo</h3><div>Estudiar el valor de las definiciones actuales del número de folículos por ovario y el volumen ovárico en el di
目的研究目前关于每卵巢卵泡数和卵巢体积的定义在诊断多囊卵巢综合征(PCOS)中的价值:设计:横断面研究:设计:横断面研究。受试者:经过标准化筛查确诊为多囊卵巢综合征的女性有资格被纳入多囊卵巢综合征组。未患多囊卵巢综合征的女性也可纳入多囊卵巢综合征组,这些女性接受了同样的筛查,月经周期规律,激素值正常,且无其他内分泌病变:多囊卵巢综合征妇女的每卵巢卵泡数和卵巢体积,按年龄分层。线性回归模型:研究 BMI 对每个卵巢的卵泡数和卵巢体积的影响。多囊卵巢综合征表型之间每卵巢卵泡数和卵巢体积的差异,以及卵巢体积与每卵巢卵泡数相比的附加值:共纳入了 2492 名患有多囊卵巢综合症的女性(16 - 50 岁)和 152 名未患有多囊卵巢综合症的女性。大多数患有多囊卵巢综合征的女性在 35 岁之前,每个卵巢的卵泡数≥ 20 个(87.8 - 100%)(使用频率≥ 8 MHz 的超声波换能器)或≥ 12 个(95.1 - 98.6%)(使用频率< 8 MHz 的换能器),35 岁之后,每个卵巢的卵泡数开始下降。无论使用哪种超声换能器,每个年龄组的中位卵巢体积都低于 10 mL 临界值。在每个年龄组中,患有多囊卵巢综合症的女性每个卵巢的卵泡数和卵巢体积均高于未患有多囊卵巢综合症的女性。在我们的队列中,如果不将卵巢体积作为多囊卵巢形态的标志,13/2297 名患有多囊卵巢综合症的女性(0.6%)就不会被诊断出多囊卵巢综合症。对于两种超声换能器,表型 A(排卵功能障碍 + 高雄激素 + 多囊卵巢形态)的女性每个卵巢的卵泡数和卵巢体积最高,其次是表型 D(排卵功能障碍 + 多囊卵巢形态),然后是表型 C(高雄激素 + 多囊卵巢形态),最后是表型 B(排卵功能障碍 + 高雄激素)(调整年龄后,所有 p 值均 < 0.001)。BMI与每个卵巢的卵泡数或卵巢体积之间未发现有临床意义的相关性:结论:由于每个卵巢的卵泡数会随着年龄的增长而减少,因此应根据年龄类别确定每个卵巢的卵泡数标准。卵巢体积随年龄下降的趋势不明显,鉴别力较低,因此可将其排除在诊断标准之外。
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引用次数: 0
A long road ahead: medical management for endometriosis-related pain. Just keep looking 前路漫漫:子宫内膜异位症相关疼痛的医疗管理。继续寻找
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.11.015
Jose Carugno M.D. , Amira Quevedo M.D. , Nash S. Moawad M.D., M.S.
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引用次数: 0
Unveiling the burden of hypoestrogenism 揭示雌激素水平低下的负担。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.11.023
Seifeldin Sadek M.D. , Amanda M. Ryan M.D. , Amr S. El Haraki M.D.
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引用次数: 0
Highlighting the importance of identity formation and the implications for psychological well-being among donor conceived individuals 强调身份形成的重要性和对捐赠者怀孕个体心理健康的影响。
IF 6.6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-02-01 DOI: 10.1016/j.fertnstert.2024.11.027
Mary P. Riddle Ph.D.
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引用次数: 0
期刊
Fertility and sterility
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