NCT02884258

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

5.9 years

First QC Date

July 26, 2016

Last Update Submit

November 15, 2019

Conditions

Keywords

Assisted Reproductive TechnologyObesityBariatric SurgeryInfertilityFertility Preservation

Outcome Measures

Primary Outcomes (1)

  • Live birth rates

    number of live births divided by the number of embryo transfers

    nine months after embryo transfer

Secondary Outcomes (1)

  • average number of mature oocytes obtained

    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.

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women underoing IVF and having undergone bariatric surgery

You may qualify if:

  • Undergoing IVF and with a history of bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Mathilde

Rouen, 76100, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

InfertilityObesity

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 30, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations