NCT03476759

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

3.5 years

First QC Date

March 18, 2018

Last Update Submit

November 26, 2021

Conditions

Tubal Factor Infertility

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    The number of pregnant women in both groups

    After 1year

Other Outcomes (1)

  • Affordability

    Within 1year

Study Arms (2)

Tubal adhesiolysis

ACTIVE COMPARATOR

laparoscopic tubal adhesiolysis and\\or tuboplasty

Procedure: Tubal adhesiolysis

IVF/ICSI

ACTIVE COMPARATOR

These patients will undergo IVF/ICSI

Drug: IVF/ICSI

Interventions

Tubal adhesiolysisPROCEDURE

125 patients will undergo tubal adhesiolysis or tuboplasty

Tubal adhesiolysis
IVF/ICSIDRUG

125 patients will undergo IVF-ICSI procedures.

IVF/ICSI

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

Location

Study Officials

  • Ayman Dawood, MD

    Lecturer at Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 26, 2018

Study Start

May 1, 2018

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations

EG(1)