Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-09 @ 4:19 AM
Study NCT ID:
NCT01674894
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2012-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Cleavage of the Egg in Relation to the Stimulation Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 356}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-25', 'studyFirstSubmitDate': '2012-08-21', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)', 'timeFrame': 'Week 1 after oocyte retrieval'}, {'measure': 'Time for disappearance of pronuclei in transferred embryos', 'timeFrame': 'Week 1 after oocyte retrieval'}, {'measure': 'Time for first cleavage in transferred embryos', 'timeFrame': 'Week 1 after oocyte retrieval'}, {'measure': 'Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos', 'timeFrame': 'Week 1 after oocyte retrieval'}, {'measure': 'Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage', 'timeFrame': 'Week 1 after oocyte retrieval'}], 'secondaryOutcomes': [{'measure': 'Total dose of gonadotrophin used', 'timeFrame': '1 month'}, {'measure': 'Gonadotrophin dose per oocyte retrieved', 'timeFrame': '1 month'}, {'measure': 'Number of oocytes retrieved', 'timeFrame': '1 month'}, {'measure': 'Number of fertilized and cleaved oocytes', 'timeFrame': '1 month'}, {'measure': 'Number of preembryos with top quality', 'timeFrame': '1 month'}, {'measure': 'Implantation rate', 'timeFrame': '2 months'}, {'measure': 'Ongoing pregnancy rate week 7', 'timeFrame': '3 months'}, {'measure': 'Live birth rate', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Female Infertility']}, 'descriptionModule': {'briefSummary': 'This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '38 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women suffering from infertility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. IVF/ICSI treatment\n2. Regular cycles of 25-35 days\n3. Follicle stimulation with Bravelle and/or Menopur\n4. Women aged 38-35 years\n5. Long agonist or short antagonist treatment\n6. Willing and able to understand a Danish, English or German patient information form\n7. Willing and able to provide written Informed Consent\n\nExclusion Criteria:\n\n1. BMI more than 35\n2. Presence of hydrosalpinx on ultrasound\n3. FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation\n4. Known allergic reactions to the planned medications\n5. Use of testicular sperm'}, 'identificationModule': {'nctId': 'NCT01674894', 'briefTitle': 'Study of the Cleavage of the Egg in Relation to the Stimulation Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Kinetics in Time-lapse Culture of Human Preembryos', 'orgStudyIdInfo': {'id': '000063'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Women treated with Menopur'}, {'label': 'Group 2', 'description': 'Women treated with Menopur and Bravelle'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frederiksberg', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Danish Fertility Clinic', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}