Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-21 @ 6:01 AM
Study NCT ID:
NCT02835469
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 412}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-07-13', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': '10-11 weeks after embryo transfer', 'description': 'Defined as presence of at least 1 intrauterine pregnancy with a viable fetus'}], 'secondaryOutcomes': [{'measure': 'Mean Follicle Stimulating Hormone (FSH) level', 'timeFrame': 'At baseline and last stimulation day (max 20 days after start of stimulation)'}, {'measure': 'Mean Luteinizing Hormone (LH) level', 'timeFrame': 'At baseline and last stimulation day (max 20 days after start of stimulation)'}, {'measure': 'Mean Estradiol 2 (E2) level', 'timeFrame': 'At baseline and last stimulation day (max 20 days after start of stimulation)'}, {'measure': 'Mean endometrial thickness', 'timeFrame': 'On last stimulation day (max 20 days after start of stimulation)', 'description': 'Measured by transvaginal ultrasound'}, {'measure': 'Follicular development', 'timeFrame': 'On last stimulation day (max 20 days after start of stimulation)', 'description': 'Number and size of follicles measured by transvaginal ultrasound'}, {'measure': 'Number of oocytes retrieved', 'timeFrame': '36 hours (±2h) after human Chorionic Gonadotrophin (hCG) administration'}, {'measure': 'Fertilization rate', 'timeFrame': '1 day after oocyte retrieval', 'description': 'Number of oocytes with 2 pronuclei divided by number of metaphase II oocytes'}]}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Fertility clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Decision made to prescribe Menopur® multidose according to Summary of product characteristics\n* The study cycle will be either\n\n * 1st controlled ovarian stimulation cycle ever, or\n * 2nd controlled ovarian stimulation cycle ever, or\n * 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)\n\nExclusion Criteria:\n\n* Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)\n* Diagnosed as "poor responder", defined as either\n\n * \\>20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or\n * any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or\n * development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle\n* Ovarian hyperstimulation syndrome (OHSS)'}, 'identificationModule': {'nctId': 'NCT02835469', 'briefTitle': 'A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'Non-Interventional Clinical Study on Efficacy and Safety of Highly Purified Human Menopausal Gonadotrophin (HP-hMG) Menopur® Multidose in Korean Female Patients With Infertility', 'orgStudyIdInfo': {'id': '000258'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Menopur® Multidose', 'description': 'Treatment according to routine clinical practice.', 'interventionNames': ['Drug: Menotrophin']}], 'interventions': [{'name': 'Menotrophin', 'type': 'DRUG', 'otherNames': ['Menopur® Multidose'], 'armGroupLabels': ['Menopur® Multidose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gwangju', 'country': 'South Korea', 'facility': 'CL Hospital (there may be other sites in this country)', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}