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临床试验/NCT05966558
NCT05966558招募中不适用

Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

Zagazig University1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2020年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
266
试验地点
1
主要终点
The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.

研究概览

简要总结

the presence of cesarean section niche has adverse effects on success of ART outcome

详细描述

A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.

It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

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 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All women should have the following:
  • Aged from 18 - 37 years old.
  • Undergoing fresh ICSI cycles.
  • A normal uterus with no anomalies or pathologies.
  • At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).
  • Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).

排除标准

  • Younger than 18 or older than 37 years old.
  • Congenital uterine abnormality or pathology.
  • Presence of a hydrosalpinx.
  • Chronic diseases which are not suitable for pregnancy.
  • ICSI cycles with fresh or frozen TESE samples.

结局指标

主要结局

The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.

时间窗: 2 years

cesarean section scar niche will be measured by TVS

次要结局

未报告次要终点

研究者

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

Rana Nabil Mohamed Attia

Assistant lecturer of obstetrics and gynaecology

Zagazig University

研究点 (1)

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