Laparoscopic Tubal Adhesiolysis Versus IVF-ICSI

Tubal Factor Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476759
• Other study ID #: Tanta University
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Tubal Factor Infertility

Intervention

Procedure:
• Tubal adhesiolysis
125 patients will undergo tubal adhesiolysis or tuboplasty

Drug:
• IVF/ICSI
125 patients will undergo IVF-ICSI procedures.

Locations

Country	Name	City	State
Egypt	Ayman Shehata Dawood	Tanta	Algharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Affordability	Costs of each maneuver	Within 1year
Primary	clinical pregnancy rate	The number of pregnant women in both groups	After 1year