Progesterone Vaginal Gel or Combined Medication for Luteal-Phase Support of Frozen-Thawed Embryo Transfer Cycles: A Single-Centre, Chinese, Randomized, Open-Label, Pilot Study.

IF 2.3 4区 医学 Q2 OBSTETRICS & GYNECOLOGY
Ningning Pan, Xiumei Zhen, Yanhong Fan, Jianhuai Zheng, Yuanyuan Wang, Qiao Liu, Xun Liao, Rui Yang
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Abstract

Objectives: This study aimed to explore potential differences in efficacy between vaginal progesterone (VPG) and VPG + oral progesterone (OPG) for luteal-phase support in hormone replacement therapy-frozen embryo transfer (HRT-FET) cycles.

Design: A single-centre, open-label, randomized controlled, phase IV pilot study was conducted.

Participants/materials, setting, methods: Infertile women aged 20-38 years undergoing HRT-FET cycles were included. Participants were randomized to VPG (n = 86) or VPG + OPG (n = 86). The primary efficacy endpoint was ongoing pregnancy at 10-12 weeks. Secondary efficacy endpoints included β-human chorionic gonadotropin (β-hCG) positivity, implantation rate, and clinical-pregnancy rate. Safety analyses included adverse events (AE) and vital signs.

Results: A higher ongoing pregnancy rate was observed with VPG + OPG (29.1%) versus VPG (18.8%); treatment difference 8.4% (90% confidence interval [CI] -2.2%, 19.0%). Numerical differences also favoured VPG + OPG over VPG for β-hCG positivity (0.9% [90% CI: -10.8%, 12.7%]), implantation (10.4% [90% CI: 0.5%, 21.3%]), and clinical pregnancy (10.1% [90% CI: -0.8%, 21.1%]). Incidences of treatment-emergent AEs were comparable.

Limitations: The single-centre study was limited by a relatively small sample size which could have impacted the reported outcomes. Another limitation was the open-label design, which might have increased the risk of bias for subjective endpoints, such as AE reporting.

Conclusions: A higher ongoing pregnancy rate was observed with VPG + OPG vs VPG; however, a statistical conclusion cannot be reached considering the small sample size. These data suggest that a minimum daily progesterone dose, such as VPG 90 mg + OPG 20 mg reported here, or VPG 180 mg reported in other studies, may be required for successful outcomes following HRT-FET cycles.

黄体酮阴道凝胶或联合用药对冻融胚胎移植周期黄体期的支持:单中心,中国,随机,开放标签,试点研究。
目的:本研究旨在探讨阴道孕酮(VPG)和VPG+口服孕酮(OPG)在激素替代疗法-冷冻胚胎移植(HRT-FET)周期中黄体期支持的潜在疗效差异。设计:单中心、开放标签、随机对照、IV期先导研究。参与者/材料、环境、方法:包括20-38岁接受HRT-FET周期的不孕妇女。参与者随机分为VPG组(n=86)或VPG+OPG组(n=86)。主要疗效终点为持续妊娠10-12周。次要疗效终点包括β-人绒毛膜促性腺激素(β-hCG)阳性、着床率和临床妊娠率。安全性分析包括不良事件(AE)和生命体征。结果:VPG+OPG组持续妊娠率(29.1%)高于VPG组(18.8%);治疗差异8.4%(90%置信区间[CI] -2.2%, 19.0%)。数值差异在β-hCG阳性(0.9% [90% CI -10.8%, 12.7%])、植入(10.4% [90% CI 0.5%, 21.3%])和临床妊娠(10.1% [90% CI -0.8%, 21.1%])方面也优于VPG+OPG。治疗后突发不良事件的发生率具有可比性。局限性:单中心研究受样本量相对较小的限制,这可能会影响报道的结果。另一个限制是开放标签设计,这可能会增加主观终点的偏倚风险,例如AE报告。结论:VPG+OPG组比VPG组持续妊娠率更高;但由于样本量较小,无法得出统计结论。这些数据表明,HRT-FET周期后的成功结果可能需要每日最低孕酮剂量,如本研究报道的VPG 90 mg+OPG 20 mg,或其他研究报道的VPG 180 mg。
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来源期刊
CiteScore
4.20
自引率
4.80%
发文量
44
审稿时长
6-12 weeks
期刊介绍: This journal covers the most active and promising areas of current research in gynecology and obstetrics. Invited, well-referenced reviews by noted experts keep readers in touch with the general framework and direction of international study. Original papers report selected experimental and clinical investigations in all fields related to gynecology, obstetrics and reproduction. Short communications are published to allow immediate discussion of new data. The international and interdisciplinary character of this periodical provides an avenue to less accessible sources and to worldwide research for investigators and practitioners.
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