Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-28 @ 11:48 PM
Study NCT ID:
NCT01430650
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2011-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Priming for Embryo Transfer
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': 'C099102', 'term': 'IDS 89 Sabal serrulata extract'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2011-06-20', 'studyFirstSubmitQcDate': '2011-09-07', 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between day means in endometrial priming to achieve 7 mm.', 'timeFrame': '11-16 days'}], 'secondaryOutcomes': [{'measure': 'Biochemical Pregnancy rate', 'timeFrame': '26-30 days', 'description': 'To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.'}, {'measure': "The patient's adherence to the recommended treatment.", 'timeFrame': '1-16 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oral estrogens', 'transdermal estrogens', 'endometrial priming'], 'conditions': ['Sterility']}, 'descriptionModule': {'briefSummary': 'The aim of this trial is compare two different endometrial priming protocols\n\n* women that receive oral estrogens\n* women that receive transdermal estrogens'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women between 18-50 years old with desire of children and needs of embryo transfer.\n* Plasma prolactin less than 30.\n* Uterine cavity that allow pregnancy, body mass index between 20-30.\n* And signed consent inform.\n\nExclusion Criteria:\n\n* History of estrogen dependent cancer, unknown origin vaginal bleeding.\n* Ovarian cyst.\n* Contraindications to be pregnant.\n* Estrogen allergy.'}, 'identificationModule': {'nctId': 'NCT01430650', 'briefTitle': 'Endometrial Priming for Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.', 'orgStudyIdInfo': {'id': 'UREP-PREPENDO-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral strogen', 'interventionNames': ['Drug: Oral strogen']}, {'type': 'EXPERIMENTAL', 'label': 'Transdermal strogen', 'interventionNames': ['Drug: Transdermal strogen']}], 'interventions': [{'name': 'Oral strogen', 'type': 'DRUG', 'description': '2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.', 'armGroupLabels': ['Oral strogen']}, {'name': 'Transdermal strogen', 'type': 'DRUG', 'description': 'One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.', 'armGroupLabels': ['Transdermal strogen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Miguel Angel Checa', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}