Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-13 @ 7:55 AM
Study NCT ID:
NCT02884258
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2016-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVF Outcome After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-15', 'studyFirstSubmitDate': '2016-07-26', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rates', 'timeFrame': 'nine months after embryo transfer', 'description': 'number of live births divided by the number of embryo transfers'}], 'secondaryOutcomes': [{'measure': 'average number of mature oocytes obtained', 'timeFrame': '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.', 'description': 'the average number of mature oocytes obtained per IVF cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Assisted Reproductive Technology', 'Obesity', 'Bariatric Surgery', 'Infertility', 'Fertility Preservation'], 'conditions': ['Infertility', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '33083823', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women underoing IVF and having undergone bariatric surgery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing IVF and with a history of bariatric surgery'}, 'identificationModule': {'nctId': 'NCT02884258', 'briefTitle': 'IVF Outcome After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Mathilde'}, 'officialTitle': 'In Vitro Fertilization (IVF) Outcome After Bariatric Surgery: a Multicentric Case-control Study.', 'orgStudyIdInfo': {'id': 'IVF after Bariatric surgery'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bariatric surgery group', 'description': 'Women undergoing IVF (IVF or ICSI) with a history of bariatric surgery (surgery procedures include sleeve gastrectomies and by-passes). No intervention is involved.'}, {'label': 'Control Group', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76100', 'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Mathilde', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Mathilde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}