Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-27 @ 10:41 AM
Study NCT ID:
NCT03115320
Status:
TERMINATED
Last Update Posted:
2024-08-22
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frozen-thawed Embryo Transfer in a Natural Cycle: hCG Triggering Versus LH Home Test
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': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'High cancellation rate in LH test group in interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2016-11-17', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': 'At possible delivery (about 40 weeks)', 'description': 'Live birth rate'}], 'secondaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': 'After two weeks', 'description': 'Ongoing pregnancy rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the LH surge home test when transferring frozen-thawed embryo in a natural cycle.', 'detailedDescription': 'The aim of this study is to find out the best method for the ovulation triggering. We study the live birth rates in the both groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\- Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos\n* Regular menstruation cycle\n* Patient's willingness to participate in the study\n\nExclusion Criteria:\n\n* \\- Irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo\n* No frozen embryos after IVF cycle\n* Allergy to Pregnyl® or some of its ingredients in the medication or other contraindications due to Pregnyl®"}, 'identificationModule': {'nctId': 'NCT03115320', 'briefTitle': 'Frozen-thawed Embryo Transfer in a Natural Cycle: hCG Triggering Versus LH Home Test', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'A Protocol for a Randomized, Two-Parallel-group Study to Compare the Efficacy of Testing LH Surge at Home Versus Medically Triggered Ovulation With hCG (Pregnyl®) in the Naturally Stimulated Cycle in the Frozen-thawed Embryo Transfer', 'orgStudyIdInfo': {'id': 'R16172M'}, 'secondaryIdInfos': [{'id': '2016-003959-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregnyl (Human chorionic gonadotropin)', 'description': 'In this group, patients have natural cycle in frozen-thawed embryo transfer and the ovulation is confirmed by administration of hCG (Pregnyl® 5000 IU). The day of transferring embryo is depending on the day of administration of hCG and the age of the embryo. The day zero day is defined by ovulation triggered by hCG.', 'interventionNames': ['Drug: Human chorionic gonadotropin']}, {'type': 'OTHER', 'label': 'Home ovulation test', 'description': 'The patients randomized to the LH surge group perform the ovulation home test daily from the urine. Thus, the ovulation in this group is corfimed by the urine test. The day of transferring embryo is depending on the positive ovulation test and the age of the embryo. The day zero day is defined by positive ovulation test.', 'interventionNames': ['Other: Home ovulation test']}], 'interventions': [{'name': 'Human chorionic gonadotropin', 'type': 'DRUG', 'otherNames': ['Home ovulation test'], 'description': 'Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.', 'armGroupLabels': ['Pregnyl (Human chorionic gonadotropin)']}, {'name': 'Home ovulation test', 'type': 'OTHER', 'description': 'The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.', 'armGroupLabels': ['Home ovulation test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Helena Tinkanen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}