Comparison Between Effects of Dydrogesterone, Cetrorelix Acetate and Triptorelin on Intra Cytoplasmic Sperm Injection Outcomes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved.
研究概览
简要总结
To compare the effects of Duphaston compared to GnRH agonist and antagonist on the prevention of premature LH surge and quality of retrieved oocytes and embryos in women undergoing intra-cytoplasmic sperm injection.
详细描述
Study Design:
A randomized clinical trial (RCT).
Study Site:
The study will be conducted at Beni-Suef University Hospital Assisted Reproductive Techniques center. The study population includes all infertile women undergoing IVF at Beni-Suef University ART center will be included. Women will be recruited for enrollment when they come to fertility clinic and scheduled for ICSI trial. They will be counseled and asked to participate in the study after been evaluated to ensure fulfilling inclusion and exclusion criteria.
Study Sample:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having indications for ICSI.
排除标准
- •Any known contraindications to the approved fertility drugs.
- •Severe endometriosis.
- •Uterine malformations or abnormal uterine cavity.
- •Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.
- •Severe male factor for infertility.
研究组 & 干预措施
GnRH antagonist
For pituitary suppression, the patients receives GnRH antagonist (CETROTIDE 0.25MG , MERCK SERONO, Germany) 0.25 mg/day subcutaneously since the dominant follicles reached the diameter of 12-14 mm till trigger day.
干预措施: Cetrorelix acetate (Drug)
Dydrogesterone
For pituitary suppression, the patients receives Dydrogesterone (Duphaston 10 mg/twice daily, Abbott Healthcare, America) orally since day 2-3.
干预措施: Dydrogesterone (Drug)
GnRH agonist
For pituitary suppression, the patients receives (Decapeptyl, sc 0.1 mg/day) beginning in the afternoon of the 21st day of the cycle prior to stimulation
干预措施: Triptorelin (Drug)
结局指标
主要结局
Number of oocytes retrieved.
时间窗: 1cycle (1 month)
number of oocytes
maturity of oocytes retrieved.
时间窗: 1 cycle (1month)
either M2 or M1
次要结局
- Duration of stimulation(1 ICSI cycle (1 month))
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University