Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 680
- 主要终点
- Biochemical Pregnancy
研究概览
简要总结
The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.
详细描述
Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit.
Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
- •No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
- •Patients with unexplained primary infertility.
排除标准
- •Patients undergoing IVF using other protocols of induction.
- •Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
- •Other causes of infertility rather than unexplained factor.
- •Unexplained poor responders during the pending ICSI cycle.
- •Patients with abnormal findings at hysteroscopy.
结局指标
主要结局
Biochemical Pregnancy
时间窗: 2-6 weeks
Pregnancy determined by chemical test (2 weeks) and vag. U/S (ultrasound) (6 weeks)
次要结局
未报告次要终点
研究者
Amr Abdulreheem
Dr
Ain Shams Maternity Hospital