Raperport Claudia, Chronopoulou Elpiniki, Petrie Aviva, Homburg Roy, Timlick Elizabeth, Barhate Sheetal, Sackett Kristina, Bhide Priya
Women's Health Research Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Whittington Health NHS Trust, London, UK.
BJOG. 2025 Aug;132(9):1220-1227. doi: 10.1111/1471-0528.18171. Epub 2025 Apr 21.
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).
An open-label, parallel-arm, single-centre randomised controlled trial.
One tertiary NHS-funded fertility unit.
Couples with UI for at least 1 year.
A comparison of luteal phase micronised vaginal progesterone treatment (400 mg bd) with timed intercourse and timed intercourse alone for 3 cycles.
Primary outcome: Livebirth rate.
Biochemical pregnancy, clinical pregnancy, mid-luteal serum progesterone and pregnancy loss.
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).
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.
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.
比较自然周期中黄体期补充孕酮与期待治疗对不明原因不孕症（UI）女性活产率的影响。
一项开放标签、平行组、单中心随机对照试验。
一家由英国国家医疗服务体系（NHS）资助的三级生殖医学中心。
患有UI至少1年的夫妇。
比较黄体期微粒化阴道孕酮治疗（400mg，每日两次）联合定时性交与单纯定时性交，共进行3个周期。
主要结局：活产率。
生化妊娠、临床妊娠、黄体中期血清孕酮水平及妊娠丢失情况。
143对夫妇被随机分组。治疗组活产率为11/72（15.3%），对照组为5/71（7.0%）（相对危险度2.17，95%可信区间0.79 - 5.93）。治疗组生化妊娠率为15/72（20.8%），对照组为10/71（14.1%）（相对危险度1.48，95%可信区间0.72 - 3.07）；治疗组临床妊娠率为14/72（19.4%），对照组为9/71（12.7%）（相对危险度1.53，95%可信区间0.71 - 3.31）。妊娠丢失情况：治疗组4/15，对照组5/10（相对危险度0.53，95%可信区间0.19 - 1.51）。每组各有1例生化妊娠丢失，治疗组2/15流产，对照组3/10流产。包括生化妊娠丢失在内的总流产率为3/15（20%）对4/10（40%）（相对危险度0.5，95%可信区间0.14 - 1.77）。
结果未达到统计学显著性。然而，活产率的差异值得进一步研究，因为这种简单、无创、低成本的治疗方法对受影响的夫妇来说是一个非常有吸引力的选择。计划开展一项更大规模的试验，根据本研究的效应量来指导样本量的确定。
PiNC试验于2019年11月29日在欧盟临床试验注册中心注册，网址为www.clinicaltrialsregister.eu/ctr-search/search?query=homerton。首位参与者于2020年2月25日入组。
