Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
试验速览
- 阶段
- 3 期
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol level on implantation is not clearly defined . There is a significant difference in estradiol levels between fertile and infertile cycles of fertile women who underwent donor insemination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants included in this study will have the following criteria : ( 2 of 3 criteria )
- •advanced maternal age or any other risk factor for POR :
- •Age ≥35 years
- •other risk factor of poor responder : ovarian surgery especially in case of endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single ovary, chronic smoking, and unexplained Infertility.
- •previous poor ovarian response : Number of oocytes at the pickup time 3 or less .
- •Abnormal ovarian reserve tests :
- •FSH ≥12 mIu/ml in the early follicular phase .
- •Estradiol level more than 70 pg/dl in the early follicular phase
- •Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.
- •Antral follicle count (AFC) < 5-7 follicles .
排除标准
- •Age >35 with good ovarian response .
- •any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
- •Severe male factor infertility.
- •Extended endometriosis (stage 3 or more) .
- •All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer
研究组 & 干预措施
oral estradiol " estradiol valerate
this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI .This group will receive oral estradiol " estradiol valerate " (Cyclo-Progynova® , 2mg , Bayer Schering Pharma Ag , Germany ) from within 24 hours ovum pickup of the cycle.
干预措施: Estradiol Valerate (Drug)
placebo
this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI . This group will receive oral placebo (tablets) from within 24 hours ovum pickup of the cycle
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
live birth rate
时间窗: at least 28 weeks after ET
the number of deliveries that resulted in a live born neonate
次要结局
未报告次要终点
研究者
Radwa Rasheedy Ali
Principal Investigator
Ain Shams University