Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT03831659
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Migraine and Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'migraine', 'timeFrame': 'At inclusion', 'description': 'Prevalence of migrainous in infertile women'}], 'secondaryOutcomes': [{'measure': 'migraine', 'timeFrame': 'At 2 months', 'description': 'Prevalence of migrainous in infertile women'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine', 'in vitro fertilization', 'infertility'], 'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the prevalence of migraine in infertile women and during in Vitro Fertilization protocol. Migraine is two to three times as common in women as in men. Migraine has considerable impact on quality of life. In Vitro Fertilization has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely linked to migraine and its fluctuations have been considered to trigger migrainous headaches.', 'detailedDescription': 'In Vitro Fertilization has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely linked to migraine and its fluctuations have been considered to trigger migrainous headaches.\n\nBoth migraine and infertility are associated with impaired quality of life.\n\nObjectives: to assess the prevalence of migraine in infertile women and during in Vitro Fertilization protocol in order to improve the management of these patients.\n\nProtocol:\n\nWomen coming to consult at the Port Royal infertility center and meeting the inclusion (infertile women without long-term analgesic treatment) criteria will be offered the study. The information note and no objection form will be given by the gynecologist receiving them for consultation. After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches. The patient fills it immediately and gives it to the investigator. As part of the usual management, and regardless of their answers to the questionnaire, some of the patients will be reviewed in consultation for the programming of an IVF. During this "incoming" consultation with one of the midwives of the unit, a schedule of migraine headaches will be given to the patients. They will keep it, will complete it in case of migraine, and will give it to the gynecologist during the embryo transfer or the doctor receiving the couple in consultation on day 7 in case of absence of embryo transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Unit of assisted reproductive medicine in a University hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertile women supported in reproductive medical assistance at the Port Royal infertility center\n* aged between 18 and 40 years old\n\nExclusion Criteria:\n\n* long-term analgesic treatment\n* women under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT03831659', 'acronym': 'FERTIMIG', 'briefTitle': 'Migraine and Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Prevalence of Migraine in Infertile Women and Evolution During in Vitro Fertilization (IVF)', 'orgStudyIdInfo': {'id': 'APHP180064'}}, 'armsInterventionsModule': {'interventions': [{'name': 'self-questionnaires', 'type': 'OTHER', 'description': 'After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Port-Royal', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}