CS Scar Impact on ART Outcomes

November 20, 2023 updated by: Ahmed Elsayed Hassan Hamed Elbohoty, HealthPlus Fertility Center
CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways

Study Overview

Status

Recruiting

Conditions

Detailed Description

CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways; increase difficulty of embryo transfer, presence intrauterine fluid at the time of transfer can affect the chances of embryo implantation and increase the rate of spontaneous miscarriages To compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a NICHE) after euploid embryo transfer. Does CS scar and CS scar defect affect IVF outcome? All women who underwent an embryo transfer with a Euploid embryo between 2015 and 2022, who meet the inclusion criteria will be included in the study.

  • Inclusion Criteria: Age 25-40 years old. Euploid embryo transfer. Medically free BMI less tha 30 kg/m2 Hormone therapy preparation for FET.
  • Exclusion criteria Previous uterine scar other than cesarean section. Congenital uterine abnormalities Presence of intrauterine lesions e.g., polyp, fibroid, Endometriosis or adenomyosis Hydrosalpinx, Chronic endometritis
  • Primary outcome: Clinical pregnancy rate, defined as a pregnancy with a detectable heart rate at 7 weeks of gestation or beyond.
  • Secondary outcomes : Early pregnancy complications Ectopic pregnancy or Miscarriage. Caesarean section scar dehiscence or

Study Type

Observational

Enrollment (Estimated)

510

Contacts and Locations

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

Study Locations

  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Recruiting
        • HealthPlus fertility Centre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Amani Kanan, specialist

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

No

Sampling Method

Probability Sample

Study Population

All women who underwent an embryo transfer with a Euploid embryo between 2005 and 2022, who meet the inclusion criteria will be included in the study. To compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a NICHE) after euploid embryo transfer.

Description

Inclusion Criteria:

  • Age 25-40 years old.

Euploid embryo transfer.

Medically free

BMI less tha 30 kg/m2

Hormone therapy preparation for FET.

Exclusion Criteria:

- Exclusion criteria

Previous uterine scar other than cesarean section.

Congenital uterine abnormalities

Presence of intrauterine lesions e.g., polyp, fibroid,

Endometriosis or adenomyosis

Hydrosalpinx, Chronic endometritis

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

Cohorts and Interventions

Group / Cohort
patient without scar
history of euploid embryo transfer
patient with cs scar no Niche
history of euploid embryo transfer
patient with cs scar with niche
history of euploid embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CS scar impact on ART outcomes, Retrospective Cohort Study
Time Frame: 2015 to 2022,
Clinical pregnancy rate
2015 to 2022,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ART outcomes
Time Frame: 2015 to 2022,

Early pregnancy complications:

Ectopic pregnancy or Miscarriage.

Caesarean section scar dehiscence or rupture.

Presence of intrauterine fluid accumulation at the time of ET.

Endometrial thickness at the time of ET.

Live birth.
2015 to 2022,

Collaborators and Investigators

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

Sponsor

HealthPlus Fertility Center

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)

June 15, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/2023/P38

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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