Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

Not Applicable

Completed

• Conditions: Tubal Factor Infertility
• Interventions: Procedure: Tubal adhesiolysis; Drug: IVF/ICSI

• Registration Number: NCT03476759
• Lead Sponsor: Tanta University

Brief Summary

2groups with peritoneal adhesions after cesarean delivery will be allocated to either laparoscopic tubal adhesiolysis or to IVF/ICSI

Detailed Description

This randomized clinical trial will be conducted at Tanta university hospitals in fertility and MIS units. Two hundred and fifty 2ry infertility patients with confirmed post C.S adhesions will be included in the study and those patients will be divided randomly in two groups:

Group A:

125 patients will be undergoing laparoscopic tubal adhesiolysis and\\or tuboplasty then a widow of 12 months post operatively is given for natural conception.

Group B:

125 patients will undergo IVF-ICSI procedures. The primary outcome measure of the study will be the rate of clinical pregnancy.

Inclusion criteria:

* patient's age not exceeding 35 years old

* confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.

Exclusion criteria:

* patient's age \>35 years

* other causes of infertility as male factor contribution, any ovulatory or endocrinological disorder,

* diagnosed any degree of endometriosis

* patients with history of recurrent pregnancy loss.

* couples with prolonged sexual abstinence for any reason Detailed explanation of the aims, procedures, steps and nature of the study for the participants will be done and a written consent will be signed by each patient before inclusion.

After allocation laparoscopic tubal adhesions will be dissected and normal anatomy and function will be restored. In the other group IVF/ICSI will be commenced The follow up with both groups will extend to 1year or till pregnancy is aggrieved The outcomes of the study were pregnancy rates and affordability

Study Timeline

• Study First Submitted: 2018-03-18
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-26
• Study Start: 2018-05-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• age not exceeding 35 years old with confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video CDs) as a solitary cause of their 2ry infertility.

Exclusion Criteria

• patient's age >35 years, male factor contribution, any ovulatory or endocrinological disorder, diagnosed any degree of endometriosis and patients with history of recurrent pregnancy loss. Couples with prolonged sexual abstinence for any reason will be excluded from participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tubal adhesiolysis	Tubal adhesiolysis	laparoscopic tubal adhesiolysis and\\or tuboplasty
IVF/ICSI	IVF/ICSI	These patients will undergo IVF/ICSI

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	After 1year	The number of pregnant women in both groups

Trial Locations

Locations (1)

Ayman Shehata Dawood; 🇪🇬 Tanta, Algharbia, Egypt