Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2026-04-21 @ 12:26 PM
Study NCT ID:
NCT02994550
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2016-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of FSH/LH Ratio in Controlled Ovarian Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2016-12-01', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy achievement', 'timeFrame': '3 months after drug administration', 'description': 'To report our results in terms of pregnancy per embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['FSH', 'LH', 'IVF'], 'conditions': ['Sub-Fertility']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing IVF cycles in Cruces University Hospital.\n* Signed IVF and cryopreservation informed consent.\n* Age \\>35 and \\<40 years.\n* FSH levels \\<10 mIU/ml.\n\nExclusion Criteria:\n\n* When inclusion criteria are not fulfilled'}, 'identificationModule': {'nctId': 'NCT02994550', 'briefTitle': 'Influence of FSH/LH Ratio in Controlled Ovarian Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Cruces'}, 'officialTitle': 'Influence of FSH/LH Ratio in Controlled Ovarian Stimulation ( 2/1 Ratio vs 4/1 Ratio) in >35 Years Women Undergoing IVF', 'orgStudyIdInfo': {'id': 'CEIC E14/30'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FSH/LH 2/1', 'description': 'dose: 300IU FSHrec and 150IU LHrec', 'interventionNames': ['Drug: FSH/LH']}, {'type': 'EXPERIMENTAL', 'label': 'FSH/LH 4/1', 'description': 'dose: 300IU FSHrec and 75IU LHrec', 'interventionNames': ['Drug: FSH/LH']}], 'interventions': [{'name': 'FSH/LH', 'type': 'DRUG', 'armGroupLabels': ['FSH/LH 2/1', 'FSH/LH 4/1']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Cruces', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Antonia Exposito', 'investigatorAffiliation': 'Hospital de Cruces'}}}}