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临床试验/NCT04335864
NCT04335864已完成不适用

A Clinical Trial Comparing Laparoscopic Salpingectomy Versus Hysteroscopic Proximal Tubal Occlusion on Pregnancy Rates Following ICSI (Intra-Cytoplasmic Sperm Injection) in Infertile Cases of Hydrosalpinx.

Cairo University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
Clinical pregnancy rate following ICSI

研究概览

简要总结

Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.

详细描述

Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus.

Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful.

The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking.

The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF.

This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

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

  • primary or secondary infertility cases
  • unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .

排除标准

  • Uterine factor of infertility
  • male factor of infertility
  • preexisting ovarian pathology
  • Presence of septic focus
  • medical or surgical conditions that contraindicated pregnancy

结局指标

主要结局

Clinical pregnancy rate following ICSI

时间窗: 14 days after Embryo transfer

Defined as positive qualitative bhcg(beta human chorionic gonadotropin)

次要结局

  • Ongoing pregnancy following ICSI(8 weeks after Embryo transfer)

研究者

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

Shaimaa Mostafa Mohammed Refaay El shemy

Principal investigator, Lecturer in obstetrics and gyneocolgy department, Cairo university

Cairo University

研究点 (2)

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