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Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03476759
Enrollment
300
Registered
2018-03-26
Start date
2018-05-01
Completion date
2021-10-31
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tubal Factor Infertility

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

Interventions

PROCEDURETubal adhesiolysis

125 patients will undergo tubal adhesiolysis or tuboplasty

125 patients will undergo IVF-ICSI procedures.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rateAfter 1yearThe number of pregnant women in both groups

Other

MeasureTime frameDescription
AffordabilityWithin 1yearCosts of each maneuver

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026