Effect of Growth Differentiation Factor - 8 (GDF-8) on Pregnancy Rates in GnRH-agonist ICSI Cycles: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Clinical pregnancy
研究概览
简要总结
The aim of this study is to investigate the role of GDF-8 in regulating progesterone levels during controlled ovarian stimulation in patients undergoing ICSI-ET and to evaluate its effects on pregnancy rates.
The main questions are
- Does serum GDF-8 correlate with serum Progesterone levels during ovarian stimulation?
- Does serum GDF-8 serum level at different time-points during ovarian stimulation correlate with pregnancy rate?
participants will undergo ICSI-ET cycle using the long GnRH-agonist protocol and serum levels of GDF-8 and progesterone will be measured at three time-points during the trial: on day of hCG trigger administration, on day of oocyte pickup, and 14 days after embryo transfer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The study population included women who underwent their first ICSI-ET cycles due to male and/or tubal factors or unexplained infertility, aged 20-35 years, whose BMI ranged from 19-29.9 kg/m2, with regular menstrual cycles
排除标准
- •women with PCOS, couples with azoospermic husbands, women with poor ovarian reserve testing (AMH < 1.2 ng/dl and/or AFC < 5), women diagnosed with endometriosis, and women with medical comorbidities such as thyroid disorders, DM, hyperprolactinemia, etc.
结局指标
主要结局
Clinical pregnancy
时间窗: 5 weeks after embryo transfer
visualization of intra-uterine gestational sac with a pulsating fetal pole within 5 weeks of embryo transfer
Serum Growth Differentiation Factor - 8 (GDF-8)
时间窗: three time-points: on day of trigger, on day of OPU, and 14 days after ET
serum levels of GDF-8
次要结局
未报告次要终点
研究者
Mervat Sheikhelarab Elsedeek Ibrahim Omran
Professor of Obstetrics and Gynaecology
University of Alexandria