Progesterone Luteal Support in Natural Cycles for Unexplained Infertility: A Randomised Controlled Trial (The PiNC Trial).
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Authors
Raperport, Claudia
Chronopoulou, Elpiniki
Petrie, Aviva
Homburg, Roy
Timlick, Elizabeth
Barhate, Sheetal
Sackett, Kristina
Bhide, Priya
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Issue Date
25/03/2025
Type
Journal Article
Language
Keywords
Infertility
Alternative Title
Abstract
Objective: To compare the effect of luteal-phase progesterone supplementation in natural cycles to expectant management onlive 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 timedintercourse alone for 3 cycles.Main Outcome Measures: Primary outcome: Livebirth rate. Secondary Outcomes: Biochemical pregnancy, clinical pregnancy,mid-luteal serum progesterone and pregnancy loss.Results: One hundred and forty-three couples were randomised. Livebirth rates were 11/72 (15.3%) in the treatment group ver-sus 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 thecontrol 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 inves-tigation as this simple, noninvasive, inexpensive treatment would be a very attractive option for affected couples. A larger trialusing 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.This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work isproperly cited.© 2025 The Author(s). BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.
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Citation
BJOG. 2025 ;132(9):1220-1227
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Journal
BJOG: An International Journal of Obstetrics & Gynaecology
Volume
132.0
Issue
9.0