Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-28 @ 12:21 PM
Study NCT ID:
NCT02244866
Status:
COMPLETED
Last Update Posted:
2014-12-25
First Post:
2014-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Pergoveris in Aged IVF Patients
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': 'C551396', 'term': 'pergoveris'}, {'id': 'D015292', 'term': 'Glycoprotein Hormones, alpha Subunit'}, {'id': 'C571801', 'term': 'follitropin alfa'}], 'ancestors': [{'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D007986', 'term': 'Luteinizing Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D013972', 'term': 'Thyrotropin'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-23', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2014-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': '7 weeks after embryo transfer', 'description': 'Clinical pregnancy is defined by the image gestational sac under ultrasonography.'}, {'measure': 'Live birth', 'timeFrame': 'at the time of delivery', 'description': 'Live birth is defined if a live newborn delivered.'}], 'secondaryOutcomes': [{'measure': 'Total FSH international units (IU) used for stimulation', 'timeFrame': 'Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days', 'description': 'Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IVF', 'LH supplementation', 'ovarian stimulation', 'poor responder'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '25740882', 'type': 'DERIVED', 'citation': 'Vuong TN, Phung HT, Ho MT. Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged >/=35 years: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1188-95. doi: 10.1093/humrep/dev038. Epub 2015 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.\n\nStudy hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.', 'detailedDescription': "A randomized controlled single center study.\n\nBased on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.\n\nEligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.\n\nOvarian stimulation was performed by using GnRH antagonist protocol.\n\nFollitropin alfa (recombinant FSH) was administered on day 2 or day 3 of the menstrual cycle. The first FSH dose was determined according to each individual patient, based on the process as follows:\n\n* AFC ≤ 6: 300 IU/day\n* AFC 7-15: 225 IU/day\n* AFC ≥ 16: 150 IU/day\n\nGnRH antagonist (Cetrotide, Merck-Serono) was administered on day 5 of FSH administration.\n\n* Recombinant LH (in the form of Pergoveris) was supplemented from day 6 of FSH administration. Patients in the Pergoveris group would be administered a reduced dose of recombinant FSH (reduced by 150 IU/day) which was replaced with Pergoveris (150IU FSH + 75IU LH)/day.\n* The Follitropin alpha group retained recombinant FSH. In both groups, if the number of developing follicles was inappropriate, the dose could be titrated depending on the physician's judgment.\n\nMonitoring the follicular development was performed by vaginal ultrasound probe, quantifying LH, estradiol and progesterone, starting from day 5 of FSH, based on the current processes of the hospital.\n\nOPU and embryo transfer: OPU was performed 36 hours after hCG administration. Embryos were transferred on day 2.\n\nLuteal phase support: daily vaginal progesterone\n\nPregnancy testing and ultrasound: a pregnancy test was done 14 days after embryo transfer. Beta hCG \\> 5mIU/ml was considered positive. Fetal ultrasound was performed 3 weeks after a positive pregnancy test to verify clinical pregnancy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 35 years\n* body mass index \\<28 kg/m2\n* had ≤ 3 previous IVF attempts\n* receiving a GnRH-antagonist protocol\n* agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.\n* have given written informed consent with the understanding that the subject may withdraw consent at any time\n\nExclusion Criteria:\n\n* participating in another interventional clinical trial\n* PCOS or WHO group 1\n* have uterine abnormalities\n* have endocrine disorders such as hyperprolactinemia, thyroid disorders'}, 'identificationModule': {'nctId': 'NCT02244866', 'briefTitle': 'Efficacy of Pergoveris in Aged IVF Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vietnam National University'}, 'officialTitle': 'A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years', 'orgStudyIdInfo': {'id': 'NCKH/CGRH_01_2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pergoveris (FSH and LH)', 'description': '150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection', 'interventionNames': ['Drug: Pergoveris (FSH and LH)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Follitropin alpha (FSH)', 'description': '150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection', 'interventionNames': ['Drug: Follitropin alpha (FSH)']}], 'interventions': [{'name': 'Pergoveris (FSH and LH)', 'type': 'DRUG', 'otherNames': ['Pergoveris'], 'description': 'Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.', 'armGroupLabels': ['Pergoveris (FSH and LH)']}, {'name': 'Follitropin alpha (FSH)', 'type': 'DRUG', 'otherNames': ['Gonal-F'], 'description': 'Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.', 'armGroupLabels': ['Follitropin alpha (FSH)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'An Sinh Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Tuong M Ho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CGRH, School of Medicine, Vietnam National University HCMC, Vietnam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vietnam National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Manh Tuong Ho', 'investigatorAffiliation': 'Vietnam National University'}}}}