Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI in Cases of Post Caesarean Section Adhesions, Which is the Best?

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

Study Overview

• Status: Completed
• Conditions: Tubal Factor Infertility
• Intervention / Treatment: Procedure: Tubal adhesiolysis; Drug: 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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Algharbia
    • Tanta, Algharbia, Egypt, 31111
      • Ayman Shehata Dawood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tubal adhesiolysis; laparoscopic tubal adhesiolysis and\or tuboplasty	Procedure: Tubal adhesiolysis; 125 patients will undergo tubal adhesiolysis or tuboplasty
Active Comparator: IVF/ICSI; These patients will undergo IVF/ICSI	Drug: IVF/ICSI; 125 patients will undergo IVF-ICSI procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	The number of pregnant women in both groups	After 1year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affordability	Costs of each maneuver	Within 1year

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Ayman Dawood, MD, Lecturer at Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: March 18, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Tanta university (Other Identifier: Tanta University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes