A Prospective, Four Arms, Open Label, Comparative Study to Assess the Ongoing Pregnancy Rate for Poor Responders Women Undergoing Different Embryo Transfer Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- ongoing pregnancy rate for poor responders women in the four arms
研究概览
简要总结
Published data on sequential transfer are limited and are not consistent. Also, further research into methods of risk combination and assessment, would allow us to help our patients make better-informed decisions about whether or not to proceed with invasive diagnostic tests as the PGS. So our study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
详细描述
The study aims to describe the ongoing pregnancy rate for poor responders women undergoing four different embryo transfer protocols among four arms within the study. Moreover, to describe the miscarriage rate, and the baseline characteristics for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.
This study is prospective, comparative, open label and multi-center study. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants.
The study materials that will be used will include blood tests, and ultrasound. The study will involve four study arms:
Arm 1: Poor responders women undergoing frozen sequential embryo transfer on Day 3 and Day 5 Arm 2: Poor responders women undergoing sequential fresh embryo transfer on Day 3 and Day 5 Arm 3: Poor responders women undergoing sequential embryo transfer on Day 3 and Day 5 after performing PGS Arm 4: Poor responders women undergoing conventional frozen embryo transfer on Day 5
Primary and secondary key measurements will be used in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The age group of these women is 25-45 years
- •Normal endometrial cavity confirmed by hysteroscopy
- •Poor responders with AMH <1
- •Patients with at least grade 1 days 3 embryo and grade 1 day 5 frozen embryos
排除标准
- •Patients with any immunological disorders
- •Patients with uncontrolled systemic diseases
- •Patients with previous uterine surgeries except for Cesarean section
结局指标
主要结局
ongoing pregnancy rate for poor responders women in the four arms
时间窗: Till the end of 12 weeks of gestation
Recording the following for the four arms of the study: * Presence of intrauterine gestational sac at 12 weeks beyond embryo transfer * Presence of fetal heart pulsation at 12 weeks beyond embryo transfer
次要结局
- miscarriage rate for poor responders women in the four arms(Till the end of 20 weeks of gestation)
- The baseline characteristics of the study participants(Before study intervention of the four arms (at day 2 in the ovulation induction cycle))
研究者
Wael Elbanna
Managing director for Wael Elbanna Clinic
Wael Elbanna Clinic