An Open-label Prospective Controlled Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle on the Ongoing Pregnancy Rate in Patients with Unexplained Infertility Undergoing Ovulation Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Signs of ongoing pregnancy
研究概览
简要总结
Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Also to describe the effect on the first trimester miscarriage rate, ectopic pregnancy rate, and multiple pregnancy.This study is an open-label, prospective, controlled study, 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 three study arms.
详细描述
Our study aims to describe the effect of the intrauterine adminstration of HCG versus the endometrial injury by pipelle on the ongoing pregnancy rate and the biochemical pregnancy rate in women with unexplained infertility undergoing ovulation induction. Also to describe the effect on the first trimester miscarriage rate, ectopic pregnancy rate, and multiple pregnancy.This study is an open-label, prospective, controlled study, 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 three study arms:
Arm 1: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger Arm 2: Women with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction Arm 3: Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of placebo on the day of trigger
Primary and secondary key measurements will be used in the study.
The primary measures will include:
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with primary or secondary infertility due to unexplained infertility
- •The age group of these women was 25-35 years
- •BMI 18.5-29.9 kg/m2
- •Normal hormone profile (FSH <10 mIU/ml on day 2-3 and AMH more than 1)
- •Euthyroid state or controlled thyroid state
- •Bilateral free spill on HSG
排除标准
- •Patients with severe male factor infertility; serum analysis count < 10 million sperms /mL - sperm motility<15% - 96%<abnormal morphology)
- •Stage III or IV endometriosis
- •Bilateral tubal factor infertility
- •Premature ovarian failure
- •Polycystic ovary syndrome
- •Uterine cavity abnormality
- •Recurrent spontaneous abortion
研究组 & 干预措施
Arm 1
Women with unexplained infertility undergoing ovulation induction following intrauterine adminstration of HCG on the day of trigger
干预措施: HCG is introduced at day of trigger intra-uterine (Drug)
Arm 2
Women with unexplained infertility undergoing ovulation induction following endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction
干预措施: endometrial injury by pipelle (Device)
结局指标
主要结局
Signs of ongoing pregnancy
时间窗: Till the end of the 1st trimester
Recording the following for the three arms of the study: * Signs of ongoing pregnancy Presence of intrauterine gestational sac at 12 weeks Presence of fetal heart pulsation at 12 weeks * Two serum β-HCG levels in 48hrs interval to emphasis biochemical pregnancy
次要结局
- occurance of abortion or ectopic or multiple pregnancy(Till the end of the 1st trimester)
- Recording the baseline characteristics of the study participants(Before study intervention)
研究者
Wael Elbanna
Managing director for Wael Elbanna Clinic
Wael Elbanna Clinic