Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-29 @ 8:19 AM
Study NCT ID:
NCT06263192
Status:
COMPLETED
Last Update Posted:
2024-02-16
First Post:
2023-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cummulative pregnancy rate', 'timeFrame': '36 months', 'description': 'Pregnancy rate after 4 cycles of IUI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti-mullerian hormone', 'infertility', 'intrauterine insemination', 'sperm donation', 'cumulative pregnancy rates'], 'conditions': ['Infertility, Female', 'Anti-Mullerian Hormone Deficiency']}, 'referencesModule': {'references': [{'pmid': '38987421', 'type': 'DERIVED', 'citation': 'Gayete-Lafuente S, Moreno-Sepulveda J, Sanchez-Alvarez J, Prat M, Robles A, Espinos JJ, Checa MA. Anti-Mullerian hormone does not predict cumulative pregnancy rate in non-infertile women following four IUI cycles with donor sperm. J Assist Reprod Genet. 2024 Sep;41(9):2319-2326. doi: 10.1007/s10815-024-03188-5. Epub 2024 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare the cumulative pregnancy rates after 4 artificial inseminations with donor (IAD) in non-sterile women with plasma AMH levels \\> and \\< 1.1 ng/mL.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '25 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes all patients between 25 and 39 years of age who have undergone IUI cycles with sperm donors', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IUI cycles with sperm donors either due to severe oligoasthenoteratozoospermia in the partner (defined as a motile sperm count (MSC) \\< 5 million in the ejaculate) or for social reasons, with up to 4 attempts accounted for.\n\nExclusion Criteria:\n\n* BMI \\>30\n* Infertility due to bilateral tubal factor\n* Endometriosis grade II-IV.'}, 'identificationModule': {'nctId': 'NCT06263192', 'briefTitle': 'Pregnancy Prediction Using Anti-Müllerian Hormone in Intrauterine Insemination Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Clinica de la Mujer Medicina Reproductiva, Chile'}, 'officialTitle': 'Pregnancy Prediction in Non-sterile Patients After 4 Intrauterine Inseminations With Donor Using Anti-Müllerian Hormone', 'orgStudyIdInfo': {'id': 'AMH-IUI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AMH < 1.1 ng/ml', 'interventionNames': ['Procedure: Intrauterine insemination']}, {'label': 'AMH > 1.1 ng/ml', 'interventionNames': ['Procedure: Intrauterine insemination']}], 'interventions': [{'name': 'Intrauterine insemination', 'type': 'PROCEDURE', 'description': 'Intrauterine insemination with sperm donors', 'armGroupLabels': ['AMH < 1.1 ng/ml', 'AMH > 1.1 ng/ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08010', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Fertty International', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Miguel Angel Checa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fertty International'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Antonio Moreno', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitat Autonoma de Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jose Antonio Moreno', 'investigatorAffiliation': 'Clinica de la Mujer Medicina Reproductiva, Chile'}}}}