Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-22 @ 2:56 PM
Study NCT ID:
NCT01614067
Status:
TERMINATED
Last Update Posted:
2021-06-15
First Post:
2012-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Delayed Start to Ovarian Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C061018', 'term': 'ganirelix'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '415-353-7475', 'title': 'Mitchell Rosen, MD', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fertilization Proportions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'OG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'timeFrame': '8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization', 'description': 'Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and no data were collected for this outcome measure'}, {'type': 'PRIMARY', 'title': 'Number of Oocytes Retrieved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'OG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'timeFrame': 'up to 1 hour after oocytes retrieved', 'description': 'The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and no data were collected for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Embryo Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'OG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'timeFrame': 'One hour on day 2 or 3 (following IVF procedure)', 'description': 'Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and no data were collected for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Pregnancy Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'OG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'timeFrame': '2 to 3 weeks following embryo transfer', 'description': 'Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value \\> 5 mIU/ml ) observed over the time frame.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and no data were collected for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Stages of Oocyte Nuclear Maturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'OG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'timeFrame': 'average of 1 to 2 hours on the Day of Retrieval', 'description': 'Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II)', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and no data were collected for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Number of Mature Follicles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'OG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'timeFrame': 'up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes)', 'description': 'Maturation of follicles will be assessed by measuring the size of follicles (mature \\> 13mm) prior to (or at the time of) oocytes retrieval.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and no data were collected for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Oocyte Recovery Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'OG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'timeFrame': 'up to 1 hours after oocyte retrieval', 'description': 'The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and no data were collected for this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'FG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Arm randomization assignment prior to starting clinical treatment cycle', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated early by sponsor and was unable to collect data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'With a goal of enrolling a total of 114 subjects, 330 potential candidates were screened for eligibility. 300 candidates were either not eligible or declined participation. 30 subjects were found eligible to participate and enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'BG001', 'title': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).\n\nGanirelix acetate: Subjects will receive 7 days of pre-treatment with the GnRH antagonist'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Female patients ages 18 years and older who were seeking IVF treatment.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Slow enrollment resulted in withdraw of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-20', 'studyFirstSubmitDate': '2012-05-02', 'resultsFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2012-06-04', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-20', 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertilization Proportions', 'timeFrame': '8 to 24 hours after in vitro fertilization, oocytes will be checked for fertilization', 'description': 'Developmental competence (fertilization of oocytes) through standard in vitro fertilization (estimated time frame to be between 8-24 hours following IVF). This percentage will be calculated as the number of fertilized eggs ( 2PN stage) per total number of eggs collected from the egg retrieval.'}, {'measure': 'Number of Oocytes Retrieved', 'timeFrame': 'up to 1 hour after oocytes retrieved', 'description': 'The egg retrieval procedure will be performed 36 hours after the ovulation trigger. The procedure is estimated to take up to 1 hour at study visit as part of routine care. The number of retrieved eggs will be counted'}], 'secondaryOutcomes': [{'measure': 'Embryo Quality', 'timeFrame': 'One hour on day 2 or 3 (following IVF procedure)', 'description': 'Embryo quality will be assessed by the embryologist on days 2 or 3 (Cleavage stage) following IVF using standard embryo grading criteria. Embryos grading is based on three criteria: the number of blastomere cells present in the embryo, the degree of observed cell fragmentation and the degree of observed symmetry of the cells.'}, {'measure': 'Pregnancy Rates', 'timeFrame': '2 to 3 weeks following embryo transfer', 'description': 'Beta HCG levels will be assessed at 2 weeks and 3 weeks after embryo transfer. A positive pregnancy is defined as two positive beta HCG levels (a value \\> 5 mIU/ml ) observed over the time frame.'}, {'measure': 'Stages of Oocyte Nuclear Maturation', 'timeFrame': 'average of 1 to 2 hours on the Day of Retrieval', 'description': 'Quality of oocytes will be assessed for developmental stages (Germinal Vesicles, Meiosis I, or Meiosis II)'}, {'measure': 'Number of Mature Follicles', 'timeFrame': 'up to 1 hour (during the Transvaginal Ultrasound before Retrieval of Oocytes)', 'description': 'Maturation of follicles will be assessed by measuring the size of follicles (mature \\> 13mm) prior to (or at the time of) oocytes retrieval.'}, {'measure': 'Oocyte Recovery Rate', 'timeFrame': 'up to 1 hours after oocyte retrieval', 'description': 'The number of oocytes recovered at the time of oocyte retrieval following ovarian stimulation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['DOR', 'Infertility', 'IVF', 'ART', 'GnRHa', 'GnRH Antagonist Protocol', 'Ganirelix'], 'conditions': ['Diminished Ovarian Reserve', 'Infertility', 'In Vitro Fertilization']}, 'referencesModule': {'references': [{'pmid': '21300334', 'type': 'BACKGROUND', 'citation': 'Blockeel C, Riva A, De Vos M, Haentjens P, Devroey P. Administration of a gonadotropin-releasing hormone antagonist during the 3 days before the initiation of the in vitro fertilization/intracytoplasmic sperm injection treatment cycle: impact on ovarian stimulation. A pilot study. Fertil Steril. 2011 Apr;95(5):1714-9.e1-2. doi: 10.1016/j.fertnstert.2011.01.028.'}]}, 'descriptionModule': {'briefSummary': 'In couples with infertility secondary to Diminished Ovarian Reserve, the investigators hypothesize that a delayed start (7 day) to ovarian stimulation with an GnRH antagonist (Ganirelix) will improve oocyte maturation and quality, and improve pregnancy outcomes.', 'detailedDescription': 'Over the past two decades, the success rate of assisted reproductive technology (ART) has dramatically increased. This increase is attributed to improvements in embryo culture, laboratory conditions, and optimization of ovarian stimulation protocols. Over the past years, there has been more interest in altering the ovarian stimulation protocol to improve outcomes. For example, recently our group found that a modification of ovulation trigger toward a more physiologic process improves oocyte quality and pregnancy outcomes. Others have suggested minimal stimulation improves in vitro fertilization (IVF) outcomes. The investigators propose to further investigate modifying the ovarian stimulation for women who have "decreased" ovarian reserve. The investigators propose that a delayed start to ovarian stimulation will improve oocyte maturation and quality and pregnancy outcomes. No published studies to date have evaluated if a delayed start to ovarian stimulation improves pregnancy outcomes. However, the investigators hypothesize that the use an antagonist for a delayed start of stimulation will work by one of two mechanisms:\n\nI. The partial suppression of FSH will allow for further recruitment of early antral follicles.\n\nII. The partial suppression of FSH will allow for further FSH responsiveness in existing follicles to synchronize the primary cohort, thereby increasing the total number of follicles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Antral Follicle Count (AFC) less than or equal to 4 as measured by transvaginal ultrasound (TVUS), or\n* Cancellation of a prior IVF cycle due to poor ovarian response.\n* Patients will receive an antagonist stimulation protocol for IVF, or IVF with Intracytoplasmic Sperm Injection (ICSI).\n\nExclusion Criteria:\n\n* Severe male factor infertility requiring surgical intervention to obtain sperm\n* Major uterine abnormality,\n* Preimplantation genetic diagnostic (PGD) testing,\n* Planned cycles without embryo transfer (for example, freeze-all, donor, or surrogate cycles).'}, 'identificationModule': {'nctId': 'NCT01614067', 'acronym': 'DOS/DOR', 'briefTitle': 'Delayed Start to Ovarian Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Delayed Start to Ovarian Stimulation Improves Oocyte Maturation and Quality: A Randomized Trial', 'orgStudyIdInfo': {'id': 'UCSF 11-07259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delayed Start', 'description': 'Study subjects will receive 7 days of pre-treatment with a GnRH antagonist (Delayed Start) before standard ovarian stimulation with FSH/LH.', 'interventionNames': ['Drug: Ganirelix acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Start', 'description': 'Ovarian stimulation with standard antagonist protocols (no delay).', 'interventionNames': ['Drug: Ganirelix acetate']}], 'interventions': [{'name': 'Ganirelix acetate', 'type': 'DRUG', 'otherNames': ['Ganirelix'], 'description': 'Subjects will receive 7 days of pre-treatment with the GnRH antagonist', 'armGroupLabels': ['Conventional Start', 'Delayed Start']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Center for Reproductive Health', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Mitchell Rosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSF Center for Reproductive Health and Fertility Preservation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}