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
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
DR REKHA R
AIIMS New Delhi
