The web-based Pleasure&Pregnancy programme in the treatment of unexplained infertility: a randomized controlled trial.

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY Human reproduction Pub Date : 2024-10-01 DOI:10.1093/humrep/deae220
F Dreischor, E A F Dancet, C B Lambalk, H W van Lunsen, D Besselink, J van Disseldorp, J Boxmeer, E A Brinkhuis, B J Cohlen, A Hoek, M de Hundt, C A H Janssen, M Lambers, J Maas, A Nap, D Perquin, M Verberg, H R Verhoeve, J Visser, L van der Voet, M H Mochtar, M Goddijn, E Laan, M van Wely, I M Custers
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The impact of an eHealth sexual health programme had yet to be evaluated by a large randomized controlled trial.</p><p><strong>Study design, size, duration: </strong>This is a nationwide multi-centre, unblinded, randomized controlled superiority trial (web-based randomization programme, 1:1 allocation ratio). This RCT intended to recruit 1164 couples within 3 years but was put on hold after having included 700 couples over 5 years (2016-2021). The web-based P&P programme contains psychosexual information and couple communication, mindfulness and sensate focus exercises aiming to help maintain or improve sexual health, mainly pleasure, and hence increase pregnancy rates. The P&P programme additionally offers information on the biology of conception and enables couples to interact online with peers and via email with coaches.</p><p><strong>Participants/materials, setting, methods: </strong>Heterosexual couples with unexplained infertility and a Hunault-prognosis of at least 30% chance of naturally conceiving a live-born child within 12 months were included, after their diagnostic work-up in 41 Dutch secondary and tertiary fertility centres. The primary outcome was an ongoing pregnancy, defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed by an ultrasound scan, conceived naturally within 6 months after randomization. Secondary outcomes were time to pregnancy, live birth, sexual health, and personal and relational well-being at baseline and after 3 and 6 months. The primary analyses were according to intention-to-treat principles. We calculated relative risks (RRs, pregnancy rates) and a risk difference (RD, pregnancy rates), Kaplan-Meier survival curves (live birth over time), and time, group, and interactive effects with mixed models analyses (sexual health and well-being).</p><p><strong>Main results and the role of chance: </strong>Totals of 352 (one withdrawal) and 348 (three withdrawals) couples were allocated to, respectively the P&P group and the expectant management group. Web-based tracking of the intervention group showed a high attrition rate (57% of couples) and limited engagement (i.e. median of 16 visits and 33 min total visitation time per couple). Intention-to-treat analyses showed that 19.4% (n = 68/351) of the P&P group and 22.6% (n = 78/345) of the expectant management group achieved a naturally conceived ongoing pregnancy (RR = 0.86; 95% CI = 0.64-1.15, RD = -3.24%; 95% CI -9.28 to 2.81). The time to pregnancy did not differ between the groups (Log rank = 0.23). Live birth occurred in 18.8% (n = 66/351) of the couples of the P&P group and 22.3% (n = 77/345) of the couples of the expectant management group (RR = 0.84; 95% CI = 0.63-1.1). Intercourse frequency decreased equally over time in both groups. Sexual pleasure, orgasm, and satisfaction of women of the P&P group improved while these outcomes remained stable in the expectant management group. Male orgasm, intercourse satisfaction, and overall satisfaction decreased over time with no differences between groups. The intervention did not affect personal and relational well-being. Non-compliance by prematurely starting medically assisted reproduction, and clinical loss to follow-up were, respectively, 15.1% and 1.4% for the complete study population. Per protocol analysis for the primary outcome did not indicate a difference between the groups. Comparing the most engaged users with the expectant management group added that coital frequency decreased less, and that male sexual desire improved in the intervention group.</p><p><strong>Limitations, reasons for caution: </strong>The intended sample size of 1164 was not reached because of a slow recruitment rate. The achieved sample size was, however, large enough to exclude an improvement of more than 8% of the P&P programme on our primary outcome.</p><p><strong>Wider implications of the findings: </strong>The P&P programme should not be offered to increase natural pregnancy rates but may be considered to improve sexual health. 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H.V. reports consulting fees from Ferring Pharmaceutical company, The Netherlands, and he is a member of the ESHRE guideline development group unexplained infertility and Chair of the Dutch guideline on unexplained infertility (unpaid). M.G. declares unrestricted research and educational grants from Ferring not related to the presented work, paid to their institution VU Medical Centre. The other authors have no conflicts to declare.</p><p><strong>Trial registration number: </strong>NTR5709.</p><p><strong>Trial registration date: </strong>4 February 2016.</p><p><strong>Date of first patient’s enrolment: </strong>27 June 2016.</p>","PeriodicalId":13003,"journal":{"name":"Human reproduction","volume":null,"pages":null},"PeriodicalIF":6.0000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Human reproduction","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/humrep/deae220","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Study question: Does offering the Pleasure&Pregnancy (P&P) programme rather than expectant management improve naturally conceived ongoing pregnancy rates in couples diagnosed with unexplained infertility?

Summary answer: The P&P programme had no effect on the ongoing pregnancy rates of couples with unexplained infertility.

What is known already: Underpowered studies suggested that face-to-face interventions targeting sexual health may increase pregnancy rates. The impact of an eHealth sexual health programme had yet to be evaluated by a large randomized controlled trial.

Study design, size, duration: This is a nationwide multi-centre, unblinded, randomized controlled superiority trial (web-based randomization programme, 1:1 allocation ratio). This RCT intended to recruit 1164 couples within 3 years but was put on hold after having included 700 couples over 5 years (2016-2021). The web-based P&P programme contains psychosexual information and couple communication, mindfulness and sensate focus exercises aiming to help maintain or improve sexual health, mainly pleasure, and hence increase pregnancy rates. The P&P programme additionally offers information on the biology of conception and enables couples to interact online with peers and via email with coaches.

Participants/materials, setting, methods: Heterosexual couples with unexplained infertility and a Hunault-prognosis of at least 30% chance of naturally conceiving a live-born child within 12 months were included, after their diagnostic work-up in 41 Dutch secondary and tertiary fertility centres. The primary outcome was an ongoing pregnancy, defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed by an ultrasound scan, conceived naturally within 6 months after randomization. Secondary outcomes were time to pregnancy, live birth, sexual health, and personal and relational well-being at baseline and after 3 and 6 months. The primary analyses were according to intention-to-treat principles. We calculated relative risks (RRs, pregnancy rates) and a risk difference (RD, pregnancy rates), Kaplan-Meier survival curves (live birth over time), and time, group, and interactive effects with mixed models analyses (sexual health and well-being).

Main results and the role of chance: Totals of 352 (one withdrawal) and 348 (three withdrawals) couples were allocated to, respectively the P&P group and the expectant management group. Web-based tracking of the intervention group showed a high attrition rate (57% of couples) and limited engagement (i.e. median of 16 visits and 33 min total visitation time per couple). Intention-to-treat analyses showed that 19.4% (n = 68/351) of the P&P group and 22.6% (n = 78/345) of the expectant management group achieved a naturally conceived ongoing pregnancy (RR = 0.86; 95% CI = 0.64-1.15, RD = -3.24%; 95% CI -9.28 to 2.81). The time to pregnancy did not differ between the groups (Log rank = 0.23). Live birth occurred in 18.8% (n = 66/351) of the couples of the P&P group and 22.3% (n = 77/345) of the couples of the expectant management group (RR = 0.84; 95% CI = 0.63-1.1). Intercourse frequency decreased equally over time in both groups. Sexual pleasure, orgasm, and satisfaction of women of the P&P group improved while these outcomes remained stable in the expectant management group. Male orgasm, intercourse satisfaction, and overall satisfaction decreased over time with no differences between groups. The intervention did not affect personal and relational well-being. Non-compliance by prematurely starting medically assisted reproduction, and clinical loss to follow-up were, respectively, 15.1% and 1.4% for the complete study population. Per protocol analysis for the primary outcome did not indicate a difference between the groups. Comparing the most engaged users with the expectant management group added that coital frequency decreased less, and that male sexual desire improved in the intervention group.

Limitations, reasons for caution: The intended sample size of 1164 was not reached because of a slow recruitment rate. The achieved sample size was, however, large enough to exclude an improvement of more than 8% of the P&P programme on our primary outcome.

Wider implications of the findings: The P&P programme should not be offered to increase natural pregnancy rates but may be considered to improve sexual health. The attrition from and limited engagement with the P&P programme is in line with research on other eHealth programmes and underlines the importance of a user experience study.

Study funding/competing interest(s): Funded by The Netherlands Organisation for Health Research and Development (ZonMw, reference: 843001605) and Flanders Research Foundation. C.B.L. is editor-in-chief of Human Reproduction. H.W.L. received royalties or licences from Prometheus Publishers Springer Media Thieme Verlag. J.B. received support from MercK for attending the ESHRE course 'The ESHRE guideline on ovarian stimulation, do we have agreement?' J.v.D. reports consulting fees and lecture payments from Ferring, not related to the presented work, and support for attending ESHRE from Goodlife and for attending NFI Riga from Merck. A.H. reports consulting fees by Ferring Pharmaceutical company, The Netherlands, paid to institution UMCG, not related to the presented work. H.V. reports consulting fees from Ferring Pharmaceutical company, The Netherlands, and he is a member of the ESHRE guideline development group unexplained infertility and Chair of the Dutch guideline on unexplained infertility (unpaid). M.G. declares unrestricted research and educational grants from Ferring not related to the presented work, paid to their institution VU Medical Centre. The other authors have no conflicts to declare.

Trial registration number: NTR5709.

Trial registration date: 4 February 2016.

Date of first patient’s enrolment: 27 June 2016.

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基于网络的 "快乐与怀孕 "计划在治疗不明原因不孕症中的应用:随机对照试验。
研究问题:提供 "快乐怀孕"(P&P)计划而非预期管理是否能提高被诊断为不明原因不孕症夫妇的自然怀孕率?P&P计划对不明原因不孕症夫妇的持续怀孕率没有影响:研究表明,针对性健康的面对面干预可能会提高怀孕率。研究的设计、规模和持续时间:这是一项全国范围的多中心、无盲、随机对照优效试验(基于网络的随机方案,1:1 分配比例)。该 RCT 原计划在 3 年内招募 1164 对夫妇,但在 5 年内(2016-2021 年)招募了 700 对夫妇后被搁置。基于网络的 P&P 计划包含性心理信息和夫妻沟通、正念和感觉集中练习,旨在帮助维持或改善性健康,主要是性快感,从而提高怀孕率。此外,P&P 计划还提供了受孕生物学方面的信息,并使夫妇能够在线与同伴互动,或通过电子邮件与教练互动。参与者/材料、环境、方法:41 家荷兰二级和三级生殖中心对不明原因不孕症夫妇进行诊断后,将他们纳入其中,并预测他们在 12 个月内自然怀上活产婴儿的几率至少为 30%。主要结果是持续妊娠,即经超声波扫描确认的至少12周的宫内存活妊娠,并在随机化后6个月内自然受孕。次要结果是怀孕时间、活产率、性健康以及基线和 3 个月及 6 个月后的个人和关系幸福感。主要分析遵循意向治疗原则。我们计算了相对风险(RRs,怀孕率)和风险差异(RD,怀孕率)、卡普兰-米尔生存曲线(活产时间)以及混合模型分析的时间、组别和交互效应(性健康和幸福感):共有 352 对(退出 1 对)和 348 对(退出 3 对)夫妇分别被分配到 P&P 组和预期管理组。对干预组的网络跟踪显示,该组的减员率较高(57%的夫妇),参与度有限(即每对夫妇的访问次数中位数为 16 次,总访问时间为 33 分钟)。意向治疗分析显示,19.4% 的 P&P 组(n = 68/351)和 22.6%的预期管理组(n = 78/345)实现了自然受孕(RR = 0.86;95% CI = 0.64-1.15,RD = -3.24%;95% CI -9.28-2.81)。两组的怀孕时间没有差异(对数等级 = 0.23)。P&P组中有18.8%的夫妇(n = 66/351)生下了活产儿,而预期管理组中有22.3%的夫妇(n = 77/345)生下了活产儿(RR = 0.84; 95% CI = 0.63-1.1)。随着时间的推移,两组的性交频率同样有所下降。P&P组女性的性快感、性高潮和满意度有所提高,而预期管理组的这些结果保持稳定。男性的性高潮、性交满意度和总体满意度则随着时间的推移而下降,组间没有差异。干预措施没有影响个人和人际关系的幸福感。在整个研究人群中,因过早开始医学辅助生殖而导致的不依从率和临床随访损失率分别为15.1%和1.4%。按方案进行的主要结果分析表明,两组之间没有差异。将参与度最高的使用者与预期管理组进行比较后发现,干预组的同房频率下降较少,男性性欲有所提高:由于招募速度较慢,未能达到 1164 个样本的预期规模。然而,已达到的样本量足够大,足以排除P&P计划对我们的主要结果有超过8%的改善:研究结果的广泛影响:P&P 计划不应该用来提高自然怀孕率,但可以考虑用来改善性健康。P&P项目的自然减员和有限参与与其他电子健康项目的研究结果一致,并强调了用户体验研究的重要性:由荷兰卫生研究与发展组织(ZonMw,编号:843001605)和佛兰德斯研究基金会资助。C.B.L. 是《人类生殖》杂志的主编。H.W.L. 从 Prometheus Publishers Springer Media Thieme Verlag 获得版税或许可证。J.B.
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来源期刊
Human reproduction
Human reproduction 医学-妇产科学
CiteScore
10.90
自引率
6.60%
发文量
1369
审稿时长
1 months
期刊介绍: Human Reproduction features full-length, peer-reviewed papers reporting original research, concise clinical case reports, as well as opinions and debates on topical issues. Papers published cover the clinical science and medical aspects of reproductive physiology, pathology and endocrinology; including andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, early pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues.
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