Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT02018159
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos
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': 'D008596', 'term': 'Menotropins'}], 'ancestors': [{'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 738}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-25', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2013-12-17', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of direct cleavage from 1 to 3 and from 2 to 5 cells', 'timeFrame': '1 week after oocyte retrieval'}, {'measure': 'Incidence of uneven blastomeres at the 2 and 4 cell stage', 'timeFrame': '1 week after oocyte retrieval'}, {'measure': 'Incidence of bi- and multinucleation at 2 cell and 4 cell stage', 'timeFrame': '1 week after oocyte retrieval'}, {'measure': 'Incidence of Smooth Endoplasmatic Reticulum at the Metaphase II stage, the Pro Nuclei stage and the 2, 3 and 4 cell stage', 'timeFrame': '1 week after oocyte retrieval'}], 'secondaryOutcomes': [{'measure': 'Positive serum human Chorion Gonadotrophin (hCG) rate', 'timeFrame': '13-15 days after transfer'}, {'measure': 'Implantation rate', 'timeFrame': '5 weeks after transfer'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '7 weeks after transfer'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '10 weeks after transfer'}, {'measure': 'Live birth rate', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women seeking fertility treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-45 years\n* In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol\n* Receiving follicle stimulation with Menopur 600/1200 IU'}, 'identificationModule': {'nctId': 'NCT02018159', 'briefTitle': 'An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'orgStudyIdInfo': {'id': '000102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women treated with Menopur', 'description': 'Women treated with Menopur can participate with more than one cycle. 700 cycles will be enrolled.', 'interventionNames': ['Drug: menotropin']}], 'interventions': [{'name': 'menotropin', 'type': 'DRUG', 'otherNames': ['Menopur'], 'armGroupLabels': ['Women treated with Menopur']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Horsens', 'country': 'Denmark', 'facility': 'Fertilitetsklinikken Hospitalsenheden Horsens, Regionshospitalet Horsens (there may be other sites in this country)', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}