IVF Outcome After Bariatric Surgery

November 15, 2019 updated by: Clinique Mathilde

In Vitro Fertilization (IVF) Outcome After Bariatric Surgery: a Multicentric Case-control Study.

This case-control study compares IVF results and live birth rates in women undergoing IVF with a history of bariatric surgery as compared to 2 age-matched control groups composed of (A) non-operated women matched on cases' post-operative BMI (controls 1) and (B) non-operated severely obese women (controls 2).

Study Overview

Status

Completed

Conditions

Detailed Description

A preliminary study in the participating center showed a trend to lower ovarian response to stimulation and live birth rates after bariatric surgery compared to weight-matched patients. However, statistical significance was not reached, as the sample size was small.

The aim of the research project is to study the ovarian response and live birth rates of this bariatric surgery population, with a sufficient number of patients, in order to reach higher statistical power. This case-control study will involve 3 IVF (in-vitro fertilization) centers in France . All patients undergoing IVF with a history of bariatric surgery will be included from January 2012. Each case will be matched for BMI and age to the 2 next patients without bariatric surgery history and undergoing IVF and to one non-operated severely obese woman. Surgery procedures include sleeve gastrectomies and by-passes. The IVF results and live birth rates will be compared between the three groups.

Study Type

Observational

Enrollment (Actual)

249

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

  • France
      • Rouen, France, 76100
        • Clinique Mathilde

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

18 years to 43 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women underoing IVF and having undergone bariatric surgery

Description

Inclusion Criteria:

  • Undergoing IVF and with a history of bariatric surgery

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
Bariatric surgery group
Women undergoing IVF (IVF or ICSI) with a history of bariatric surgery (surgery procedures include sleeve gastrectomies and by-passes). No intervention is involved.
Control Group
1. Women undergoing IVF with no history of bariatric surgery and matched to bariatric surgery patients for weight, parity and age. 2. non-operated severely obese women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rates
Time Frame: nine months after embryo transfer
number of live births divided by the number of embryo transfers
nine months after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
average number of mature oocytes obtained
Time Frame: The day of oocyte retrieval in the case of IVF with sperm injection (ICSI) just after decoronisation, or on day one after oocyte retrieval in classical IVF. Oocyte retrieval occurs 36 hours after hCG injection after an ovarian stimulation protocol.
the average number of mature oocytes obtained per IVF cycle
The day of oocyte retrieval in the case of IVF with sperm injection (ICSI) just after decoronisation, or on day one after oocyte retrieval in classical IVF. Oocyte retrieval occurs 36 hours after hCG injection after an ovarian stimulation protocol.

Collaborators and Investigators

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

Sponsor

Clinique Mathilde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVF after Bariatric surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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