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临床试验/NCT05358678
NCT05358678招募中不适用

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

Rahem Fertility Center1 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2022年5月25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 scar niche and its characteristics on ongoing pregnancy rate of ART cycles.

研究概览

简要总结

To evaluate the impact of the presence of cesarean section niche and its characteristics on the outcome of ART cycles.

详细描述

The incidence of Cesarean section (CS) is increasing worldwide, with a corresponding increase in its associated complications. The well-known complications are infection, hemorrhage, and increased risk of obstetric complications in subsequent pregnancies, like morbidly adherent placenta, cs scar pregnancies and uterine rupture.

In addition, some studies emphasize the effect of cesarean sections on reduced fertility. A meta-analysis reported that a Caesarean section reduces the probability of subsequent pregnancy by 10%, compared with a previous vaginal delivery.

The cesarean section niche is 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. Meanwhile, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.

The detection of a cesarean section niche depends on the operator and the diagnostic method used. This can be 2D, 3D transvaginal sonography, sonohysterography or hysteroscopy.

Regarding ART, the presence of cs niche was reported to reduce the chances of embryo implantation, and increase the rate of spontaneous miscarriages, especially if the implantation is close to it or in the niche.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The effect of cesarean scar niche and its characteristics on ongoing pregnancy rate of ART cycles.

时间窗: 3 months

Ongoing pregnancy: defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed on an ultrasound scan

次要结局

  • Clinical pregnancy(6 weeks)

研究者

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

Eman Elgindy

Professor of obstetrics and Gynecology Zagazig University Faculty of Medicine

Rahem Fertility Center

研究点 (1)

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