Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2018-05-01
2021-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tubal adhesiolysis
laparoscopic tubal adhesiolysis and\\or tuboplasty
Tubal adhesiolysis
125 patients will undergo tubal adhesiolysis or tuboplasty
IVF/ICSI
These patients will undergo IVF/ICSI
IVF/ICSI
125 patients will undergo IVF-ICSI procedures.
Interventions
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Tubal adhesiolysis
125 patients will undergo tubal adhesiolysis or tuboplasty
IVF/ICSI
125 patients will undergo IVF-ICSI procedures.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
35 Years
FEMALE
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Ayman S Dawood, MD
Principal investigator
Principal Investigators
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Ayman Dawood, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer at Tanta University
Locations
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Ayman Shehata Dawood
Tanta, Algharbia, Egypt
Countries
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Other Identifiers
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Tanta University
Identifier Type: -
Identifier Source: org_study_id