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Completed

NCT Number: NCT03854292

Hydrosalpinx Management Before Intracytoplasmic Sperm Injection

ICSI pregnancy outcomes following hysteroscopic tubal electrocoagulation versus laparoscopic tubal disconnection for patients with hydrosalpinges

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Key information

Conditions

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

Tubal factor of infertility resulting from various forms of tuboperitoneal damage remains an extremely common cause of female infertility, accounting for more than 35% of all cases of female infertility. Probably the most severe form of tubal pathology is hydrosalpinx. Hydrosalpinx is a Greek word that means a Fallopian tube filled with water or fluid. Patients with hydrosalpinges have been identified as a subgroup with significantly lower implantation and pregnancy rates than patients with other tubal pathologies. An increased risk for early pregnancy loss and increased risk for ectopic pregnancies was reported, and many studies confirmed that the presence of hydrosalpinx significantly impairs in vitro fertilization (IVF) outcome as well.

Patients with a hydrosalpinx have been found to have significantly poorer outcomes of IVF than do patients with tubal factor infertility but no hydrosalpinx .

Hydrosalpinges in infertile women reduce the success of IVF by 50 % .

The harmful effect of a hydrosalpinx on pregnancy rates after IVF has been attributed to mechanical washout of the transferred embryos by tubal-uterine reflux of the hydrosalpinx fluid .

Additionally, a hydrosalpinx might disturb endometrial receptivity: integrins, the best endometrial markers, show decreased expression in cases of hydrosalpinx .

Altered endometrial blood flow has also been proposed as a possible factor causing decreased rates of implantation.

Any surgical interventions that disrupt tubal-uterine communication in affected tubes might improve pregnancy rates .

Laparoscopic salpingectomy was the most popular treatment option offered by the clinicians, followed by open salpingectomy, salpingostomy, proximal tubal occlusion and transvaginal ultrasonographic guided hydrosalpinx aspiration either before or during oocyte retrieval.The latest treatment option introduced was proximal occlusion of the hydrosalpinx by hysteroscopic placement of microinserts. Clinicians would still perform open salpingectomy. The possible explanation for this could be the lack of training in endoscopic surgery and/or that patients with tubal disease may have significant pelvic adhesions necessitating open surgery.

Laparoscopic salpingectomy or tubal ligation has been shown to improve IVF outcomes for patients with a hydrosalpinx.

However, this procedure has many drawbacks, including its invasiveness, the possibility of surgical injury (e.g. visceral injury, vascular damage, or unintended laparotomy), the potential risks from general anesthesia, and technical difficulty if there are pelvic adhesions .

The proximal occlusion of a hydrosalpinx by hysteroscopy might offer a feasible therapeutic alternative when laparoscopy is technically difficult or contraindicated,with the advantage of hysteroscopic procedures of faster recovery, less hospitalization and rapid return to work, and in the future it might be done in the outpatient clinic as an office procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 20 to 35 years
  • Primary or secondary infertility.
  • Diagnosis of hydrosalpinx; diagnosed by HSG and TV U/S.
  • Necessity of an IVF procedure.

Exclusion criteria

  • Patients with uterine factor infertility.
  • Medical or surgical conditions contraindicating pregnancy.
  • Poor responders according to reference criteria.
  • Cases of polycystic ovary disease.

Treatment and study plan

Hysteroscopic tubal electrocoagulation

Procedure

Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopicelectrocoagulating roller ball.

Primary outcomes

  1. proximal tubal occlusion Success rate .

    Time frame: 15 months

    proximal tubal occlusion Success rate among two groups detected by Hysterosalpingogram.

Secondary outcomes

  1. Pregnancy rate among the two groups.

    Time frame: 15 months

    Chemical Pregnancy rate among the two groups.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

ICSI Pregnancy Outcomes Following Hysteroscopic Tubal Electrocoagulation Versus Laparoscopic Tubal Disconnection for Patients With Hydrosalpinges

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2019
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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