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临床试验/NCT06529627
NCT06529627已完成不适用

Effect of Growth Differentiation Factor - 8 (GDF-8) on Pregnancy Rates in GnRH-agonist ICSI Cycles: A Prospective Cohort Study

University of Alexandria1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Serum Growth Differentiation Factor - 8 (GDF-8)

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.

研究组 & 干预措施

Long agonist protocol - ICSI-ET

Active Comparator

干预措施: Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection (Procedure)

结局指标

主要结局

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mervat Sheikhelarab Elsedeek Ibrahim Omran

Professor of Obstetrics and Gynaecology

University of Alexandria

研究点 (1)

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