Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

July 19, 2023 updated by: Rana Nabil Mohamed Attia, Zagazig University
the presence of cesarean section niche has adverse effects on success of ART outcome

Study Overview

Status

Recruiting

Conditions

Detailed Description

A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.

It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

Study Type

Observational

Enrollment (Estimated)

266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.

Description

Inclusion Criteria:

  • All women should have the following:

    • Aged from 18 - 37 years old.
    • Undergoing fresh ICSI cycles.
    • A normal uterus with no anomalies or pathologies.
    • At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).
    • Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).

Exclusion Criteria:

  • Younger than 18 or older than 37 years old.
  • Congenital uterine abnormality or pathology.
  • Presence of a hydrosalpinx.
  • Chronic diseases which are not suitable for pregnancy.
  • ICSI cycles with fresh or frozen TESE samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.
Time Frame: 2 years
cesarean section scar niche will be measured by TVS
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9385-22-3-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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