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临床试验/NCT03581422
NCT03581422已完成不适用

Frozen-Thawed Embryo Transfers: a Comparison Between Natural Cycles With Spontaneous or Induced Ovulation

Istituto Clinico Humanitas0 个研究点目标入组 2,866 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,866
主要终点
CPR in NCFET vs mNCFET

研究概览

简要总结

In recent years, frozen-thawed embryo transfer procedure (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle: which is the best preparation protocol remains a matter of debate.

A retrospective analysis was conducted between 2012-2017. The aim was comparing clinical pregnancy rate (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer with hCG-triggered ovulation (mNC-FET).

详细描述

Compared to repeated oocyte retrieval procedure, frozen-thawed embryo transfer (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle, with demonstrated superiority in preventing ovarian hyperstimulation syndrome and improving cost-efficiency and time to pregnancy.

It is controversial whether triggering ovulation of the dominant follicle using human chorionic gonadotrophin (hCG) may benefit or reduce embryo implantation, when compared with a natural cycle environment. Unfavourable clinical outcomes of controlled ovarian stimulation have been reported by recently published studies, compared to the spontaneous LH surge.

This study aimed to compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration\with hCG-triggered ovulation (mNC-FET).

A retrospective analysis was conducted between 2012-2017. In patients with regular ovulatory cycles, the timing of embryo thawing and transferring was based on spontaneous LH surge (NC-FET). Patients attended for ultrasound evaluation of the dominant follicle from Day 8 to 10 of their menstrual cycle (depending on cycle length), detecting luteinizing hormone (LH) surge in urine/ taking an ovulation test for urinary LH measurement. In selected cases, a serum assays of LH, progesterone and estradioI has been further obtained. When the endometrial thickness reached 8 mm and dominant follicle 16-20 mm in diameter, hCG was administered in absence of urinary LH surge. Embryo thawing and transfer was planned 7 days after LH surge or HCG administration, whether G5 or G6 blastocyst. Exogenous progesterone supplementation started 2 days after hCG administration versus the same day of embryo transfer procedure in NC- ET. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a (Pre Gestational Test for aneuploydia) cycles and cleavage stage embryo transfers. A unilevel and multi level logistic regression analysis was conducted using Stata Software versione15.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • only single blastocyst transfer cycles were included

排除标准

  • PGT-a cycles and cleavage stage embryo transfers

研究组 & 干预措施

mNC-FET

modified natural cycle frozen-thawed embryo transfer by hCG administration

干预措施: hCG administration before embryo transfer (Drug)

结局指标

主要结局

CPR in NCFET vs mNCFET

时间窗: 2012-2017

compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

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