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Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

Primary Purpose

Tubal Factor Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tubal adhesiolysis
IVF/ICSI
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tubal Factor Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ayman Shehata Dawood

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tubal adhesiolysis

IVF/ICSI

Arm Description

laparoscopic tubal adhesiolysis and\or tuboplasty

These patients will undergo IVF/ICSI

Outcomes

Primary Outcome Measures

clinical pregnancy rate
The number of pregnant women in both groups

Secondary Outcome Measures

Full Information

First Posted
March 18, 2018
Last Updated
November 26, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT03476759
Brief Title
Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI
Official Title
Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI in Cases of Post Caesarean Section Adhesions, Which is the Best?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tubal Factor Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tubal adhesiolysis
Arm Type
Active Comparator
Arm Description
laparoscopic tubal adhesiolysis and\or tuboplasty
Arm Title
IVF/ICSI
Arm Type
Active Comparator
Arm Description
These patients will undergo IVF/ICSI
Intervention Type
Procedure
Intervention Name(s)
Tubal adhesiolysis
Intervention Description
125 patients will undergo tubal adhesiolysis or tuboplasty
Intervention Type
Drug
Intervention Name(s)
IVF/ICSI
Intervention Description
125 patients will undergo IVF-ICSI procedures.
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
The number of pregnant women in both groups
Time Frame
After 1year
Other Pre-specified Outcome Measures:
Title
Affordability
Description
Costs of each maneuver
Time Frame
Within 1year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females only
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Dawood, MD
Organizational Affiliation
Lecturer at Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayman Shehata Dawood
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
yes

Learn more about this trial

Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

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