Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 5:43 PM
Study NCT ID:
NCT05577806
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2022-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DYG Versus Cetrorelix in Oocyte Donation
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004394', 'term': 'Dydrogesterone'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live Birth Rate per transfer', 'timeFrame': '40 weeks after ET'}, {'measure': 'Clinical pregnancy per transfer', 'timeFrame': '12 weeks after ET'}, {'measure': 'Miscarriage rate', 'timeFrame': '12 weeks after ET'}], 'secondaryOutcomes': [{'measure': 'Number of oocytes retrieved', 'timeFrame': 'at time of oocyte retrieval'}, {'measure': 'Number of mature oocytes', 'timeFrame': '1 day after IVF'}, {'measure': 'Number of fertilized oocytes', 'timeFrame': '1 day after IVF'}, {'measure': 'Number of blastocists', 'timeFrame': '5-6 days after OPU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gonadotrophin-releasing hormone (GnRH) analogues', 'Ovarian stimulation', 'Oocyte donation', 'Progestin-primed ovarian stimulation', 'Dydrogesterone'], 'conditions': ['Infertility, Female', 'Fertility Disorders']}, 'descriptionModule': {'briefSummary': 'Prospective controlled study to assess the reproductive outcomes of OD recipients in which the donors were subjected to the DYG protocol (20mg/day) compared with those subjected to the short protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm. The OD cycles were triggered with triptoreline acetate and the trigger criterion was ≥3 follicles of diameter \\>18mm.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Oocyte donors undergoing controlled ovarian stimulation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oocyte donors between 21 and 30 years old, with regular menstrual cycles (24-35 d) and a body mass index (BMI) between 18 and 28 kg/m2 without any relevant personal or family history\n\nExclusion Criteria:\n\n* AMH less than 3 ng/dL\n* A positive screening for sexually transmitted diseases'}, 'identificationModule': {'nctId': 'NCT05577806', 'briefTitle': 'DYG Versus Cetrorelix in Oocyte Donation', 'organization': {'class': 'OTHER', 'fullName': 'Clinica de la Mujer Medicina Reproductiva, Chile'}, 'officialTitle': 'Comparison of Reproductive Outcomes After Progestin-primed Ovarian Stimulation With Dydrogesterone Versus Cetrorelix to Inhibit Spontaneous Ovulation in Oocyte Donation', 'orgStudyIdInfo': {'id': 'PPOS-DU-OD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DYG', 'description': 'oocyte donors undergoing controlled ovarian stimulation in a progestin-primed ovarian stimulation protocol with DYG protocol (20mg/day)', 'interventionNames': ['Drug: Dydrogesterone']}, {'label': 'Cetrorelix', 'description': 'oocyte donors undergoing controlled ovarian stimulation in a GnRH antagonist protocol with cetrorelix (0.25 mg/day) from Day 7 or since a leading follicle reached 14 mm'}], 'interventions': [{'name': 'Dydrogesterone', 'type': 'DRUG', 'description': 'progestin primed ovarian stimulation', 'armGroupLabels': ['DYG']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica de la Mujer Medicina Reproductiva, Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jose Antonio Moreno', 'investigatorAffiliation': 'Clinica de la Mujer Medicina Reproductiva, Chile'}}}}