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NCT Number: NCT02884258

IVF Outcome After Bariatric Surgery

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).

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Key information

Conditions

Infertility Body Weight Genital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–43 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinique Mathilde

Rouen, 76100, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing IVF and with a history of bariatric surgery

Treatment and study plan

Primary outcomes

  1. Live birth rates

    Time frame: nine months after embryo transfer

    number of live births divided by the number of embryo transfers

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Clinique Mathilde

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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