Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

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

Detailed Description
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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

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

Conditions
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Tubal Factor Infertility

Intervention / Treatment
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* Procedure: Tubal adhesiolysis
* Drug: IVF/ICSI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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