Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT03767218
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total amount of COC (cumulus-oocyte-complex)', 'timeFrame': 'at oocyte aspiration'}], 'secondaryOutcomes': [{'measure': 'Endocrine profile', 'timeFrame': 'on menstrual cycle day 2 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group', 'description': 'LH (Luteinising hormone) level'}, {'measure': 'Endocrine profile', 'timeFrame': 'on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group', 'description': 'FSH level'}, {'measure': 'Endocrine profile', 'timeFrame': 'on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group', 'description': 'Progesterone level'}, {'measure': 'Endocrine profile', 'timeFrame': 'on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group', 'description': 'Estradiol level'}, {'measure': 'Consumption of gonadotrophins', 'timeFrame': 'during the ovarian stimulation', 'description': 'totaal amount of IU (international units) used'}, {'measure': 'Number of days needed for ovarian stimulation', 'timeFrame': 'during the ovarian stimulation'}, {'measure': 'Days of GnRH antagonist use', 'timeFrame': 'during the ovarian stimulation'}, {'measure': 'Total number of mature oocytes', 'timeFrame': 'at day of oocyte aspiration'}, {'measure': 'Total medication cost', 'timeFrame': 'during the ovarian stimulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oocyte donor', 'Ovarian stimulation'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.', 'detailedDescription': 'Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.\n\nDesign: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio\n\nPatients: Oocyte donors (aged 18-36 years)\n\nIntervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.\n\nInvestigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) \\> 10 IU/L, till day of trigger.\n\nOocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oocyte donor patients\n* Age from 18 to 36 years\n* BMI 19 to 35\n* Regular menstrual cycle length i.e. 24-35 days\n\nExclusion Criteria:\n\n* Patients with AMH \\<1.1 ng/ml and/or AFC\\<7\n* Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH \\>5ng/ml\n* Endometriosis grade 3-4\n* Oligo-amenorrhea\n* Any untreated endocrine abnormality'}, 'identificationModule': {'nctId': 'NCT03767218', 'briefTitle': 'Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.', 'orgStudyIdInfo': {'id': 'D2.D12.Bemfola'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Late follicular phase stimulation with recombinant-human FSH', 'description': 'Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH \\> 10 IU/L, till day of trigger.', 'interventionNames': ['Combination Product: Late follicular phase stimulation with recombinant-human FSH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Early follicular phase stimulation with recombinant-human FSH', 'description': 'Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.', 'interventionNames': ['Combination Product: Early follicular phase stimulation with recombinant-human FSH']}], 'interventions': [{'name': 'Late follicular phase stimulation with recombinant-human FSH', 'type': 'COMBINATION_PRODUCT', 'description': 'Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH \\> 10 IU/L, till day of trigger.', 'armGroupLabels': ['Late follicular phase stimulation with recombinant-human FSH']}, {'name': 'Early follicular phase stimulation with recombinant-human FSH', 'type': 'COMBINATION_PRODUCT', 'description': 'Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.', 'armGroupLabels': ['Early follicular phase stimulation with recombinant-human FSH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}