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临床试验/NCT05798624
NCT05798624招募中不适用

To Study the Impact of a Previous Cesarean Section (CS) With / Without an Isthmocele on the Ongoing Pregnancy Rate in Single Euploid Frozen Embryo Transfer

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2023年5月1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
1,050
试验地点
1
主要终点
Rate of vaginal bleeding in early pregnancy (until 12 weeks of gestation)

研究概览

简要总结

As embryo ploidy is a crucial factor not only for implantation but also for maintenance of a pregnancy, the aim of this study is to evaluate the impact of the CS / isthmocele on the ongoing pregnancy rates and the implantation site in single euploid frozen embryo transfer, independent of the endometrial preparation approach.

详细描述

The impact of a previous CS on the future fertility in the general population is discussed controversially, but it seems that the clinical and social circumstances leading to the CS have a greater effect on future fertility than the surgical procedure itself (Gurol-Urganci et al., 2013, 2014; Evers et al., 2014). However, this might be different in women who do not conceive spontaneously after a previous CS and need to undergo ART due to secondary infertility. Whereas some studies describe a reduction of implantation, ongoing pregnancy, and live birth (LB) rates (Vissers et al., 2020; Wang et al., 2020; Diao et al., 2021; Friedenthal et al., 2021; van den Tweel et al., 2022), others describe a negative impact of a previous CS only in the presence of an isthmocele (Diao et al., 2021) or no impact (Patounakis et al., 2016).

A case control study evaluated whether there are any differences in the location and distance to the internal cervical ostium of the implantation site of the intrauterine gestation sacs, early pregnancy symptoms and pregnancy outcome at 12 weeks gestation between women with and without a previous Caesarean section (CS) in patients who conceived naturally (Naji et al., 2013). Investigators concluded that the presence of a CS scar affects the site of implantation, and also that the distance between implantation site and the scar is related to the risk of spontaneous abortion.

This is a purely observational study without any intervention. Participants will be stratified into different groups according to their previous obstetrical history. Total sample size will include 1050 participants undergoing a frozen embryo transfer (FET) cycle.

Isthmocele will be defined according to de Vaate et al (Bij de Vaate et al., 2011) as: visible anechogenic area of at least 1 mm depth at the site of the Cesarean scar.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All participants undergoing a single euploid FET, independent of the endometrial preparation approach

排除标准

  • Intracavitary fluid during preparation for FET
  • Known anomaly of the uterus or the adnexae (e.g.: fibroids, polyps, hydrosalpinx, endometriosis, adenomyosis)
  • Embryo which was biopsied on day 7
  • Poor quality embryo which was transferred (Gardner criteria: AC / BC / CB, biopsied on day 6 and CC embryos from both, day 5 and day 6 biopsies, classified as "poor" quality embryos)
  • History of recurrent abortion
  • Antiphospholipid syndrome / autoimmune diseases

结局指标

主要结局

Rate of vaginal bleeding in early pregnancy (until 12 weeks of gestation)

时间窗: 12 weeks

Ongoing pregnancy rate

时间窗: 5 weeks

Implantation rate

时间窗: 6 weeks

Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred

Implantation site

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

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

Barbara Lawrenz

Scientific Director

ART Fertility Clinics LLC

研究点 (1)

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