IVF Outcome After Bariatric Surgery

NCT ID: NCT02884258

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

249 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2017-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Infertility Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Undergoing IVF and with a history of bariatric surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Clinique Mathilde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Mathilde

Rouen, , France

Site Status

Countries

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France

References

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Grzegorczyk-Martin V, Freour T, De Bantel Finet A, Bonnet E, Merzouk M, Roset J, Roger V, Cedrin-Durnerin I, Wainer R, Avril C, Landais P. IVF outcomes in patients with a history of bariatric surgery: a multicenter retrospective cohort study. Hum Reprod. 2020 Dec 1;35(12):2755-2762. doi: 10.1093/humrep/deaa208.

Reference Type DERIVED
PMID: 33083823 (View on PubMed)

Other Identifiers

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IVF after Bariatric surgery

Identifier Type: -

Identifier Source: org_study_id

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