Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT05574894
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 692}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-08', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Embryo implantation', 'timeFrame': '14 days after embryo transfer', 'description': 'Positive serum HCG 14 days after embryo transfer. Implantation rate=number of embryos implanted/embryo of embryos tranferred.'}, {'measure': 'Clinical pregnancy', 'timeFrame': '30 days after embryo transfer', 'description': 'Clinical pregnancy is defined as visualization of the gestational sac on ultrasonography. Clinical pregnancy rate=number of ongoing pregnancies/number of embryos transferred.'}, {'measure': 'Ongoing pregnancy', 'timeFrame': "12 weeks' gestation", 'description': "Ongoing pregnancy is defined as a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer. Ongoing pregnancy rate=number of ongoing pregnancies/number of embryos transferred."}], 'primaryOutcomes': [{'measure': 'Proportion of cycles which obtained euploid blastocysts', 'timeFrame': '1 month after oocyte retrieval', 'description': 'Number of cycles with at least 1 euploid blastocyst divided by the total number of stimulation cycles in a cohort'}], 'secondaryOutcomes': [{'measure': 'Euploid blastocyst rate per cohort', 'timeFrame': '1 month after oocyte retrieval', 'description': 'Total number of euploid blastocyst in a cohort/total number of biopsied embryos in the same cohort'}, {'measure': 'Euploidy rate per cycle', 'timeFrame': '1 month after oocyte retrieval', 'description': 'Euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth Hormone', 'Advanced Maternal Age', 'PGT-A']}, 'referencesModule': {'references': [{'pmid': '37858247', 'type': 'DERIVED', 'citation': 'Sui Y, Xiao M, Fu J, Li L, Xu Y, Lei C, Sun X. Growth hormone supplementation during ovarian stimulation in women with advanced maternal age undergoing preimplantation genetic testing for Aneuploidy. J Ovarian Res. 2023 Oct 19;16(1):204. doi: 10.1186/s13048-023-01279-y.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.\n\nInfertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.\n\nTreatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.\n\nControl group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '38 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; normal semen analysis for the male partner\n\nExclusion Criteria:\n\n* Endometriosis grade 3 or higher, untreat hydrosalpinx;\n* Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex);\n* Untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)\n* Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;\n* Women who received other supplement drugs during ovarian stimulation'}, 'identificationModule': {'nctId': 'NCT05574894', 'briefTitle': 'Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'ShangHai Ji Ai Genetics & IVF Institute'}, 'officialTitle': 'Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'JIAI E2022-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GH group', 'description': 'Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation', 'interventionNames': ['Drug: Growth hormone', 'Drug: GnRH antagonist']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation', 'interventionNames': ['Drug: GnRH antagonist']}], 'interventions': [{'name': 'Growth hormone', 'type': 'DRUG', 'description': 'Growth hormone is supplemented during the ovarian stimulation till the day of trigger', 'armGroupLabels': ['GH group']}, {'name': 'GnRH antagonist', 'type': 'DRUG', 'description': 'GnRH antagonist protocol for ovarian stimulation', 'armGroupLabels': ['Control group', 'GH group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai JIAI Genetics and IVF Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaoxi Sun, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai JIAI Genetics and IVF Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShangHai Ji Ai Genetics & IVF Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}