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
About this trial
This is an interventional treatment trial for Tubal Factor Infertility
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.
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
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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