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Hydrosalpinx Management Before Intracytoplasmic Sperm Injection

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ClinicalTrials.gov Identifier: NCT03854292
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Marwa Mohamed Abdalla, Cairo University

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

Condition or disease Intervention/treatment
Hydrosalpinx Procedure: Hysteroscopic tubal electrocoagulation

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ICSI Pregnancy Outcomes Following Hysteroscopic Tubal Electrocoagulation Versus Laparoscopic Tubal Disconnection for Patients With Hydrosalpinges
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Group/Cohort Intervention/treatment
Hysteroscopic tubal electrocoagulation
Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopic electrocoagulating roller ball
Procedure: Hysteroscopic tubal electrocoagulation
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.

Laparoscopic tubal disconnection
Coagulation of the mid isthmus region of the affected Fallopian tube, with the bipolar forceps. using direct current that was no greater than 25 Watts.
Procedure: Hysteroscopic tubal electrocoagulation
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 Outcome Measures :
  1. proximal tubal occlusion Success rate . [ Time Frame: 15 months ]
    proximal tubal occlusion Success rate among two groups detected by Hysterosalpingogram.


Secondary Outcome Measures :
  1. Pregnancy rate among the two groups. [ Time Frame: 15 months ]
    Chemical Pregnancy rate among the two groups.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50 patients who have unilateral or bilateral hydrosalpinges identified on hysterosalpingography and vaginal ultrasonography, and who are undergoing IVF.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854292


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Publications:

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Responsible Party: Marwa Mohamed Abdalla, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03854292    
Other Study ID Numbers: tubal disconnection
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No