Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT01678651
Status:
TERMINATED
Last Update Posted:
2016-02-24
First Post:
2012-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D043373', 'term': 'Follicle Stimulating Hormone, Human'}], 'ancestors': [{'id': 'D005640', 'term': 'Follicle Stimulating Hormone'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time of cell cleavage', 'timeFrame': 'February 2012', 'description': 'Analysis of cell cleavage'}], 'secondaryOutcomes': [{'measure': 'Embryo and oocyte morphology', 'timeFrame': 'February 2012', 'description': 'Analysis of all oocytes'}, {'measure': 'Outcome rates (implantation, pregnancy and miscarriage rate)', 'timeFrame': 'February 2012', 'description': 'Time requierd to know all the implantation, pregnancy and miscarriage rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['time-lapse, FSH, kinetics'], 'conditions': ['Embryo Kinetics']}, 'descriptionModule': {'briefSummary': 'Different kinetics markers have been proposed to select embryos with higher implantation rates. The effect of external factors on these markers, such as the stimulation protocol should be analyzed. There are two different types of FSH that are commonly used for in vitro fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if there is a difference in embryo kinetics and morphology as well as oocyte morphological parameters between the two types of FSH and therefore to analyze if such markers can be used despite of the stimulation protocols chosen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•Egg donation cycles with more than 8MII in oocyte retrieval day\n\nExclusion Criteria:\n\n* Male factor\n* Uterine malformations\n* genetic alterations'}, 'identificationModule': {'nctId': 'NCT01678651', 'briefTitle': 'Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH', 'organization': {'class': 'OTHER', 'fullName': 'IVI Madrid'}, 'officialTitle': 'Embryo Kinetcis From Embryos Deriving From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH', 'orgStudyIdInfo': {'id': 'MAD-NB-08-2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Human FSH', 'description': 'Human FSH', 'interventionNames': ['Procedure: Stimulation with human FSH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant FSH', 'description': 'Recombinant FSH', 'interventionNames': ['Procedure: Stimulation with recombinant FSH']}], 'interventions': [{'name': 'Stimulation with human FSH', 'type': 'PROCEDURE', 'description': 'Human FSH', 'armGroupLabels': ['Human FSH']}, {'name': 'Stimulation with recombinant FSH', 'type': 'PROCEDURE', 'description': 'Recombinant FSH', 'armGroupLabels': ['Recombinant FSH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28023', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Insituto Valenciano de Infertilida', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IVI Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}