Progesterone Primed Ovarian Stimulation Protocol (PPOS) VS GnRH Antagonist Protocol in Patients With Expected High Ovarian Response Undergoing ICSI Cycles: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- oocytes retrieved
研究概览
简要总结
To compare the effectiveness and safety of Progesterone Primed Ovarian Stimulation protocol (PPOS) using Dydrogestrone vs GnRH Antagonist Protocol in patients with expected high ovarian response undergoing ICSI cycle
详细描述
Each patient will be subjected to:
Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.
Routine labs as CBC, liver & kidney functions to exclude general disease as a contraindication for induction or pregnancy.
Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .
For pituitary suppression, the patients will receive either Dydrogestrone (Duphaston30mg/d; Abbott Healthcare, USA) orally starting at day 2-3 or GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.
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
- •undergoing trial of 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
- •History of recurrent ICSI failure or recurrent miscarriage
研究组 & 干预措施
Dydrogestrone
For pituitary suppression, the patients will receive either Dydrogestrone (Duphaston30 mg/d; Abbott Healthcare, USA) orally starting at day 2-3
干预措施: Dydrogesterone Tablets (Drug)
GnRH antagonist
For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.
干预措施: Cetrorelix (Drug)
结局指标
主要结局
oocytes retrieved
时间窗: 1 month of induction for ICSI trial
Number of oocytes retrieved classified
次要结局
- Duration of stimulation days.(1 month)
- chemical pregnancy rate(1 month)
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University
