Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-07 @ 9:22 AM
Study NCT ID:
NCT01866618
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2013-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Cycle In Vitro Fertilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 524}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2013-05-20', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Temporal Embryonic Development', 'timeFrame': '1 Year', 'description': 'To examine the parameters of temporal embryonic development and the transcriptome of granulosa cells and follicular fluid. The embryos will be graded at standard time points to determine whether there are differences in in vitro development. Granulosa cells and follicular fluid will undergo gene expression analysis and compared to the gene expression profiles found in those specimens in stimulated cycles.'}], 'primaryOutcomes': [{'measure': 'Endometrial Changes', 'timeFrame': '1 Year', 'description': 'To examine the endometrium within the natural cycle in order to accurately characterize the differences in multiple aspects of endocrine and paracrine hormonal activity, the transcriptome of cells influencing oocyte maturation and changes in the endometrium.'}], 'secondaryOutcomes': [{'measure': 'Aneuploidy Rates', 'timeFrame': '1 Year', 'description': 'To examine aneuploidy rates in embryos from natural IVF cycles.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Natural', 'IVF Cycle'], 'conditions': ['Natural Cycle in Vitro Fertilization (IVF)']}, 'referencesModule': {'references': [{'pmid': '31561871', 'type': 'DERIVED', 'citation': 'Hong KH, Franasiak JM, Werner MM, Patounakis G, Juneau CR, Forman EJ, Scott RT Jr. Embryonic aneuploidy rates are equivalent in natural cycles and gonadotropin-stimulated cycles. Fertil Steril. 2019 Oct;112(4):670-676. doi: 10.1016/j.fertnstert.2019.05.039.'}]}, 'descriptionModule': {'briefSummary': 'Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron \\& hCG. Patients will not be given any other stimulating medications during the cycle. They will have 2 uterine aspirations and an endometrial biopsy at designated times. The first uterine aspiration will be randomized to one of four days (day before retrieval, day of retrieval, day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ovulatory cycles every 39 days or less (natural cycle IVF cannot be performed in someone who does not have cycles)\n* Must be RMANJ patient and have completed all diagnostic screening at one of our RMANJ locations. All diagnostic screening is NOT covered under the study and must be completed prior to being allowed to start the study cycle.\n\nExclusion Criteria:\n\n* Prior enrollment/attempt in this study\n* Requirement for surgical sperm extraction\n* Inability to assess ovaries via transvaginal ultrasound\n* Inability to tolerate vaginal examination'}, 'identificationModule': {'nctId': 'NCT01866618', 'briefTitle': 'Natural Cycle In Vitro Fertilization', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Natural Cycle In Vitro Fertilization', 'orgStudyIdInfo': {'id': 'RMA-2013-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Natural IVF Cycle', 'description': 'All patients will undergo a natural IVF cycle using trigger shots of Leuprolide Acetate(Lupron) and human chorionic gonadotropin (hCG) to ensure the patient surges.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Reproductive Medicine Associates of New Jersey', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}], 'overallOfficials': [{'name': 'Richard T Scott, M.D., HCLD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medicine Associates of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}