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临床试验/NCT03680690
NCT03680690Unknown不适用

Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles

Assiut University0 个研究点目标入组 244 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
244
主要终点
Clinical pregnancy rate

研究概览

简要总结

The aim of the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles.

详细描述

Intrauterine pathology has been reported in up to 25% of infertile women having IVF treatment and in as many as 50% of women with recurrent implantation failure, leading to suggestions that correction of such pathology could improve treatment outcome. Hysteroscopy allows visual assessment of the cervical canal and uterine cavity and provides the opportunity to operate in the same setting. Routine outpatient hysteroscopy before starting IVF has been postulated to diagnose and treat abnormalities of the cervix and uterine cavity and hence improve IVF outcome.

A systematic review of published studies suggested that outpatient hysteroscopy in the menstrual cycle preceding an IVF treatment cycle could significantly increase the clinical pregnancy rate in women who had previously had recurrent implantation failure, even when no hysteroscopic abnormality was detected.

However, the result of the TROPHY study - published in the Lancet in 2016 concluded that Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate and they recommended that further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted.

An MD thesis done in our department on the evaluation of the endometrial cavity in infertile patients and prior to IVF recommended that there is an urgent need to RCT to emphasize the benefit of removal of the detected intrauterine lesions before proceeding to IVF.

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
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 18 and 38 years old.
  • An indication for IVF/ICSI.
  • Normal 2D transvaginal U/S assessment of the uterine cavity, or abnormal cavity detected by 2D ,3D and HSG.
  • Women with primary or secondary infertility.
  • Women with BMI between 20 & 35.

排除标准

  • Refusal to join the study.
  • Untreated tubal hydrosalpinges.
  • Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).

结局指标

主要结局

Clinical pregnancy rate

时间窗: 7th week of pregnancy for cardiac pulsations.

Clinical pregnancy rate Will be evaluated

次要结局

  • Abortion rate(up to 28 week)
  • Implantation rate(6 weeks)
  • Chemical pregnancy rate Chemical pregnancy rate(4 weeks)
  • Preterm labour rate(9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Momen Ahmed Mohammed Kamel

Principle investigator

Assiut University

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