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临床试验/NCT02628756
NCT02628756已完成不适用

Endometrial Injury Does Not Improve Pregnancy Rates in Women With Unexplained Infertility

Mansoura Integrated Fertility Center0 个研究点目标入组 120 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
主要终点
Clinical pregnancy rates (PR)

研究概览

简要总结

Women between 18-39 years old who had been infertile (primary or secondary) for at least 1 year were recruited. In a parallel assignment eligible participants were randomized to receive either a single, site-specific endometrial injury guided by hysteroscopy (Study group) or no intervention (Control group). Natural cycle folliculometry + timed sexual intercourse were offered for all participants for the ongoing and the immediate 2 concecutive cycles. Clinical pregnancy rates were the primary outcome and miscarriage rates were the secondary outcome measures.

详细描述

A single site-specific hysteroscopic injury procedure (Snip) will be performed using an office hysteroscopy (Karl Storz, Germany). By means of vaginoscopy, a 2.9 mm. continuous-flow diagnostic hysteroscope with a 5 Fr. working-channel is guided through the cervical canal with normal saline as distension medium, with flow manually regulated through the key of the hysteroscopic sheath.

The examination of the uterine cavity begins by observing its regularity, paying special attention to the presence of intrauterine malformations or morphologic alterations such as submucous myomas, or uterine septa. Subsequently, A claw forceps will be introduced through a 2.2 mm working channel, and will be used to generate a local injury on the upper posterior endometrium (Endometrial Snip) at midline 10-15 mm from the fundus on D4 to D7 of the ongoing menstrual cycle. The depth and width of the injured site will be about 2x2 mm (i.e a single bite of the claw forceps). No premedications, antibiotics or hemostatics will be given after the procedure.

Natural cycle folliculometry + timed sexual intercourse will be offered for all participants for the ongoing and the immediate subsequent cycles. Once the leading ovarian follicle will reach a size of at least 16 mm, 10,000 IU of hCG will be administered to trigger ovulation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 18 and 39 years old.
  • Normal HSG and/or diagnostic laparoscopy.
  • Normal seminal profile.
  • Regular ovulation confirmed by mid-luteal progesterone.
  • Normal TVS criteria.

排除标准

  • Uterine fibroid.
  • Pelvic endometriosis.
  • Irregular menstruation.
  • Ovarian cysts.

结局指标

主要结局

Clinical pregnancy rates (PR)

时间窗: Three consecutive months

次要结局

  • Miscarriage rates(Three consecutive months)

研究者

发起方
Mansoura Integrated Fertility Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tarek Shokeir

Prof. Obstetrics & Gynecology

Mansoura Integrated Fertility Center

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