Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI(Intracytoplasmic Sperm Injection) a Case Control Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)
研究概览
简要总结
study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI
详细描述
This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled .
Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •infertlity indicated for ICSI
- •Ovarian factor
- •Tubal factor
- •Unexplained infertility
- •poor responders
排除标准
- •Expected high responder
- •Endometriosis
- •Male and uterine factors
- •Ovarian mass or cyst
研究组 & 干预措施
aromataze group
patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
干预措施: induction with aromataze inhibitor (Drug)
aromataze group
patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
干预措施: HMG (Drug)
aromataze group
patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
干预措施: GnRh a (Drug)
aromataze group
patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
干预措施: HCG (Drug)
classic group
same protocol for induction without aromataze inhibitor
干预措施: HMG (Drug)
classic group
same protocol for induction without aromataze inhibitor
干预措施: GnRh a (Drug)
classic group
same protocol for induction without aromataze inhibitor
干预措施: HCG (Drug)
结局指标
主要结局
Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)
时间窗: day of HCG injection
measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report
quality of ova
时间窗: day of ovum pick up
After ova picking up examination of all ova under microscope and report how many ova reach metaphase II (quality) if more than 3 ova reach metaphase II considered satisfactory quality of ova in the current cycle
次要结局
- pregnancy rate(14 days after ovum pick up)
研究者
Reham Elkhateeb
doctor
Minia University