Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate.
研究概览
简要总结
The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.
详细描述
Patients will be randomized using a list of computer generated random sample into two groups:
Group 1: Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.
Group 2: Couples who will undergo ovulation induction with clomiphene citrate. The drug chosen for ovulation induction in both groups will be clomephine citrate.
Timing and technique of endometrial sampling:
Timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. Technique: this will be done using the pipelle method (Williams et al., 2008).
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Male partner should have a normal semen count and motility according to world health organization criteria (Murray et al., 2012).
- •Primary, secondary or unexplained infertility for at least one year.
- •Failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles.
- •Age varies from 20-35 years with at least one year of infertility.
- •Body mass index between 19-30 kg/m
- •Day 2 serum FSH< 12 IU/ml.
- •Normal uterine cavity on hystrosalpingography.
- •At least one patent tube of normal appearance on HSG.
- •No previous attempts of intrauterine insemination (IUI) or in vitro fertilization (IVF).
排除标准
- •Infertility due to tubal factor or male factor.
- •Intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope.
- •Hypogonadotrophic hypogonadism.
研究组 & 干预措施
clomiphene and endometrial sampling
Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.
干预措施: endometrial sampling (Device)
clomiphene and endometrial sampling
Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.
干预措施: clomiphene citrate (Drug)
clomiphene citrate
Couples who will undergo ovulation induction with clomiphene citrate.
干预措施: clomiphene citrate (Drug)
结局指标
主要结局
Clinical pregnancy rate.
时间窗: one year
Miscarriage rate.
时间窗: one year
Multiple pregnancy rates
时间窗: one year
次要结局
未报告次要终点
研究者
mohamed maher
assisstant professor
Al Hayat National Hospital