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Completed

NCT Number: NCT03476759

Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

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

Completed

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tubal adhesiolysis

Procedure

125 patients will undergo tubal adhesiolysis or tuboplasty

IVF/ICSI

Drug

125 patients will undergo IVF-ICSI procedures.

Primary outcomes

  1. clinical pregnancy rate

    Time frame: After 1year

    The number of pregnant women in both groups

Other outcomes

  1. Affordability

    Time frame: Within 1year

    Costs of each maneuver

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2018
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.