Claudia Raperport, Elpiniki Chronopoulou, Aviva Petrie, Roy Homburg, Elizabeth Timlick, Sheetal Barhate, Kristina Sackett, Priya Bhide
{"title":"自然周期中黄体酮对不明原因不孕症的支持：一项随机对照试验（PiNC试验）","authors":"Claudia Raperport, Elpiniki Chronopoulou, Aviva Petrie, Roy Homburg, Elizabeth Timlick, Sheetal Barhate, Kristina Sackett, Priya Bhide","doi":"10.1111/1471-0528.18171","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>To compare the effect of luteal-phase progesterone supplementation in natural cycles to expectant management on live birth rates in women with unexplained infertility (UI).</p>\n </section>\n \n <section>\n \n <h3> Design</h3>\n \n <p>An open-label, parallel-arm, single-centre randomised controlled trial.</p>\n </section>\n \n <section>\n \n <h3> Setting</h3>\n \n <p>One tertiary NHS-funded fertility unit.</p>\n </section>\n \n <section>\n \n <h3> Population</h3>\n \n <p>Couples with UI for at least 1 year.</p>\n </section>\n \n <section>\n \n <h3> Method</h3>\n \n <p>A comparison of luteal phase micronised vaginal progesterone treatment (400 mg bd) with timed intercourse and timed intercourse alone for 3 cycles.</p>\n </section>\n \n <section>\n \n <h3> Main Outcome Measures</h3>\n \n <p>Primary outcome: Livebirth rate. Secondary Outcomes: Biochemical pregnancy, clinical pregnancy, mid-luteal serum progesterone and pregnancy loss.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>One hundred and forty-three couples were randomised. Livebirth rates were 11/72 (15.3%) in the treatment group versus 5/71 (7.0%) in the control group (RR 2.17, 95% CI 0.79–5.93). Biochemical pregnancy rates were 15/72 (20.8%) versus 10/71 (14.1%), (RR 1.48, 95% CI 0.72–3.07) and clinical pregnancy rates were 14/72 (19.4%) versus 9/71 (12.7%), (RR 1.53, 95% CI 0.71–3.31) in the treatment and control groups respectively. Pregnancy losses: 4/15 treatment group versus 5/10 control group (RR 0.53, 95% CI 0.19–1.51). One biochemical pregnancy loss in each group and 2/15 miscarriages in the treatment group versus 3/10 in the control group. Total miscarriage rates including biochemical losses were 3/15 (20%) versus 4/10 (40%) (RR 0.5, 95% CI 0.14–1.77).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>The results did not reach statistical significance. However, the difference in livebirth rates warrants further investigation as this simple, noninvasive, inexpensive treatment would be a very attractive option for affected couples. A larger trial using the effect size from this study to guide sample size is planned.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>The PiNC trial was registered with the EU Clinical Trials Register on 29/11/2019 www.clinicaltrialsregister.eu/ctr-search/search?query=homerton. The first participant was recruited on 25/2/2020.</p>\n </section>\n </div>","PeriodicalId":50729,"journal":{"name":"Bjog-An International Journal of Obstetrics and Gynaecology","volume":"132 9","pages":"1220-1227"},"PeriodicalIF":4.7000,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/1471-0528.18171","citationCount":"0","resultStr":"{\"title\":\"Progesterone Luteal Support in Natural Cycles for Unexplained Infertility: A Randomised Controlled Trial (The PiNC Trial)\",\"authors\":\"Claudia Raperport, Elpiniki Chronopoulou, Aviva Petrie, Roy Homburg, Elizabeth Timlick, Sheetal Barhate, Kristina Sackett, Priya Bhide\",\"doi\":\"10.1111/1471-0528.18171\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Objective</h3>\\n \\n <p>To compare the effect of luteal-phase progesterone supplementation in natural cycles to expectant management on live birth rates in women with unexplained infertility (UI).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Design</h3>\\n \\n <p>An open-label, parallel-arm, single-centre randomised controlled trial.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Setting</h3>\\n \\n <p>One tertiary NHS-funded fertility unit.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Population</h3>\\n \\n <p>Couples with UI for at least 1 year.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Method</h3>\\n \\n <p>A comparison of luteal phase micronised vaginal progesterone treatment (400 mg bd) with timed intercourse and timed intercourse alone for 3 cycles.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Main Outcome Measures</h3>\\n \\n <p>Primary outcome: Livebirth rate. Secondary Outcomes: Biochemical pregnancy, clinical pregnancy, mid-luteal serum progesterone and pregnancy loss.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>One hundred and forty-three couples were randomised. Livebirth rates were 11/72 (15.3%) in the treatment group versus 5/71 (7.0%) in the control group (RR 2.17, 95% CI 0.79–5.93). Biochemical pregnancy rates were 15/72 (20.8%) versus 10/71 (14.1%), (RR 1.48, 95% CI 0.72–3.07) and clinical pregnancy rates were 14/72 (19.4%) versus 9/71 (12.7%), (RR 1.53, 95% CI 0.71–3.31) in the treatment and control groups respectively. Pregnancy losses: 4/15 treatment group versus 5/10 control group (RR 0.53, 95% CI 0.19–1.51). One biochemical pregnancy loss in each group and 2/15 miscarriages in the treatment group versus 3/10 in the control group. Total miscarriage rates including biochemical losses were 3/15 (20%) versus 4/10 (40%) (RR 0.5, 95% CI 0.14–1.77).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>The results did not reach statistical significance. However, the difference in livebirth rates warrants further investigation as this simple, noninvasive, inexpensive treatment would be a very attractive option for affected couples. A larger trial using the effect size from this study to guide sample size is planned.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>The PiNC trial was registered with the EU Clinical Trials Register on 29/11/2019 www.clinicaltrialsregister.eu/ctr-search/search?query=homerton. 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Progesterone Luteal Support in Natural Cycles for Unexplained Infertility: A Randomised Controlled Trial (The PiNC Trial)
Objective
To compare the effect of luteal-phase progesterone supplementation in natural cycles to expectant management on live birth rates in women with unexplained infertility (UI).
Design
An open-label, parallel-arm, single-centre randomised controlled trial.
Setting
One tertiary NHS-funded fertility unit.
Population
Couples with UI for at least 1 year.
Method
A comparison of luteal phase micronised vaginal progesterone treatment (400 mg bd) with timed intercourse and timed intercourse alone for 3 cycles.
One hundred and forty-three couples were randomised. Livebirth rates were 11/72 (15.3%) in the treatment group versus 5/71 (7.0%) in the control group (RR 2.17, 95% CI 0.79–5.93). Biochemical pregnancy rates were 15/72 (20.8%) versus 10/71 (14.1%), (RR 1.48, 95% CI 0.72–3.07) and clinical pregnancy rates were 14/72 (19.4%) versus 9/71 (12.7%), (RR 1.53, 95% CI 0.71–3.31) in the treatment and control groups respectively. Pregnancy losses: 4/15 treatment group versus 5/10 control group (RR 0.53, 95% CI 0.19–1.51). One biochemical pregnancy loss in each group and 2/15 miscarriages in the treatment group versus 3/10 in the control group. Total miscarriage rates including biochemical losses were 3/15 (20%) versus 4/10 (40%) (RR 0.5, 95% CI 0.14–1.77).
Conclusions
The results did not reach statistical significance. However, the difference in livebirth rates warrants further investigation as this simple, noninvasive, inexpensive treatment would be a very attractive option for affected couples. A larger trial using the effect size from this study to guide sample size is planned.
Trial Registration
The PiNC trial was registered with the EU Clinical Trials Register on 29/11/2019 www.clinicaltrialsregister.eu/ctr-search/search?query=homerton. The first participant was recruited on 25/2/2020.
期刊介绍：
BJOG is an editorially independent publication owned by the Royal College of Obstetricians and Gynaecologists (RCOG). The Journal publishes original, peer-reviewed work in all areas of obstetrics and gynaecology, including contraception, urogynaecology, fertility, oncology and clinical practice. Its aim is to publish the highest quality medical research in women''s health, worldwide.
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