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Research Article: Live birth after letrozole-stimulated cycles versus hormone replacement treatment cycles for the first frozen embryo transfer in women with polycystic ovary syndrome: protocol for a multicentre randomised controlled trial

Date Published: 2023-08-17

Abstract:
Introduction Hormone replacement treatment (HRT) is the most commonly used endometrial preparation protocol for frozen embryo transfer (FET) in patients with polycystic ovary syndrome (PCOS). However, studies have found that HRT may increase the risk of hypertensive disorders of pregnancy and some obstetric complications. Letrozole is a new first-line ovulation induction drug for PCOS and can effectively induce spontaneous ovulation by reducing oestrogen levels. However, letrozole is still rarely used in FET and has only been reported in a few studies in Asian populations. High-quality, well-powered randomised controlled trials (RCTs) comparing HRT and letrozole-stimulated protocols are lacking. The aim of this study is to compare the efficacy and safety of two protocols in patients with PCOS. Methods and analysis This is a multicentre, open-label RCT in four reproductive medical centres in China. In total, 1078?women with PCOS will be randomised (1:1) to the letrozole-stimulated or HRT group in their first FET cycle and their pregnancy and perinatal outcomes during this cycle will be followed up and analysed. The primary outcome is live birth. Secondary outcomes are cycle cancellation rate, biochemical pregnancy, clinical pregnancy, miscarriage, ectopic pregnancy, obstetric and perinatal complications, neonatal complications and birth weight. Ethics and dissemination Ethical approval was obtained from the Institutional Review Board of Reproductive and Genetic Hospital of CITIC-XIANGYA (LL-SC-2022-001). Written informed consent will be obtained from each participant. The findings will be disseminated through conference presentations and publication in peer-reviewed journals. Trial registration number NCT05227391 .

Introduction:
Frozen embryo transfer (FET) has increased dramatically over the past decade owing to improvement of vitrification technique and wide-spread adoption of single-embryo transfer. Compared with fresh embryo transfer, FET can decrease the risk of ovarian hyperstimulation syndrome (OHSS), and increase the live birth rate (LBR), especially in polycystic ovary syndrome (PCOS)/hyper-response populations. 1 Endometrial preparation is the key to the success of FET. There are different protocols for endometrial preparation:…

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