Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Hydrosalpinx and Planning for IVF

NCT04037813 | Completed DMC

• 1 other identifier: 140689
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

compare the efficacy of hysteroscopic tubal occlusion versus laparoscopic tubal occlusion for the patients of communicating hydrosalpinx scheduled for IVF. half of the patients will undergo hysteroscopic tubal occlusion while the other half will undergo laparoscopic tubal occlusion.

Conditions

Tubal Obstruction

Keywords

Hysteroscopy; Laparoscopy; Hydrosalpinx

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with successful hysteroscopic tubal occlusion

  Successful tubal occlusion will be measured by the presence of negative spill and proximal tubal block on HSG.

  one month post-operative.

Secondary Outcomes (4)

• The percentage of patients with successful laparoscopic tubal occlusion

  one month post-operative.

• The post-operative pain in both groups (using VAS ).

  24 hours post-operative.

• The operative time and complications in both groups.

  Intra-operative duration.

• Compare the success rate of tubal occlusion in both groups.

  one month post-operative.

Study Arms (2)

Laparoscopic tubal occlusion

ACTIVE COMPARATOR

54 patients will undergo laparoscopic tubal occlusion.

Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx

Hysteroscopic tubal occlusion

ACTIVE COMPARATOR

54 patients will undergo hysteroscopic tubal occlusion.

Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx

Interventions

Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx PROCEDURE

For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area. For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut.

Hysteroscopic tubal occlusion; Laparoscopic tubal occlusion

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary or secondary infertility.
• The presence of communicating hydrosalpinx diagnosed by HSG,TV U/S showing distended tubes and intrauterine fluid or patient complaining of prolonged brownish vaginal discharge.
• Candidate for IVF procedure.

You may not qualify if:

• Uterine anomalies.
• Serious medical condition and unfit for surgery.
• Contraindication for laparoscopic tubal occlusion.
• Contraindication for pregnancy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 22222, Egypt

Location

MeSH Terms

Conditions

Fallopian Tube Diseases

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mahmoud A Abdelsalam, Msc

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in obstetrics and gynecology department

Study Record Dates

• First Submitted: July 21, 2019
• First Posted: July 30, 2019
• Study Start: August 15, 2019
• Primary Completion: August 15, 2020
• Study Completion: September 15, 2020
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)