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临床试验/CTRI/2025/04/084444
CTRI/2025/04/084444招募中2/3 期

To compare the effect of endometrial preparation using natural cycle versus hormone replacement cycle on frozen embryo transfer outcomes in ovulatory infertile women : A randomised controlled trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

This study is a randomized controlled trial comparing the effectiveness and safety of natural cycle frozen embryo transfer  versus hormone replacement cycle FET  in ovulatory infertile women Conducted at the ART Centre,Department of Obstetrics & Gynecology AIIMS New Delhi from ethical clearance to July 2026 the study will include 60 women aged 21 to 40 years with regular menstrual cycles undergoing day 5 blastocyst transfer Exclusion criteria include anovulation  systemic diseases PCOS and uterine abnormalities Participants will be randomized into two groups NC-FET where ovulation is monitored through serial transvaginal ultrasound and hormonal assessment before progesterone supplementation and embryo transfer and HRC FET where estradiol valerate is used for endometrial preparationfollowed by progesterone supplementation and embryo transfer The primary objective is to compare clinical pregnancy rates while secondary outcomes include ongoing pregnancy rate early miscarriage rate ectopic pregnancy rate  and cycle cancellation rate Statistical analysis will use descriptive and inferential tests with significance set at p less than 0.05 This study aims to provide robust evidence to guide the selection of the optimal FET protocol in ovulatory infertile women

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Infertile women awaiting day 5 (blastocyst) frozen embryo transfer with Regular menstrual cycles (24 to 38 days) with a variation of ±3 days.

排除标准

  • Anovulatory women Contraindications for hormones Presence of hydrosalpinx Uterine abnormalities Mullerian anomalies fibroid adenomyosis endometrial polyp intrauterine adhesions Chronic systemic diseases PCOS.

结局指标

主要结局

Clinical pregnancy rate

时间窗: 6 weeks

次要结局

  • Ongoing pregnancy rate(Early miscarriage rate)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR REKHA R

AIIMS New Delhi

研究点 (1)

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