Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-05 @ 5:22 PM
Study NCT ID:
NCT03088735
Status:
TERMINATED
Last Update Posted:
2021-06-29
First Post:
2017-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfer Strategy in an Oocyte Donation Programme
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'whyStopped': 'Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2017-03-18', 'studyFirstSubmitQcDate': '2017-03-18', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative live birth rate', 'timeFrame': 'at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle', 'description': 'Total number of births considering fresh and frozen thawed embryos transferred'}], 'secondaryOutcomes': [{'measure': 'Cumulative pregnancy rate', 'timeFrame': 'at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle', 'description': 'Total number of pregnancies confirmed by ultrasound 6 weeks after embryo transfer including fresh and thawed embryos.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oocyte Donation', 'Infertility, Female', 'Embryo Transfer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.dexeus.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.\n\nExclusion Criteria:\n\n* Preimplantation genetic screening or diagnosis cycles.\n* Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician."}, 'identificationModule': {'nctId': 'NCT03088735', 'briefTitle': 'Transfer Strategy in an Oocyte Donation Programme', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Dexeus'}, 'officialTitle': 'Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SMD-2017-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blastocyst-stage embryo transfer strategy', 'interventionNames': ['Procedure: Blastocyst-stage embryo transfer strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cleavage-stage embryo transfer strategy', 'interventionNames': ['Procedure: Cleavage-stage embryo transfer strategy']}], 'interventions': [{'name': 'Blastocyst-stage embryo transfer strategy', 'type': 'PROCEDURE', 'description': "Intra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mÃnimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria.", 'armGroupLabels': ['Blastocyst-stage embryo transfer strategy']}, {'name': 'Cleavage-stage embryo transfer strategy', 'type': 'PROCEDURE', 'description': 'Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients', 'armGroupLabels': ['Cleavage-stage embryo transfer strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'state': 'Barcelons', 'country': 'Spain', 'facility': 'Department Obstetric, Gynecologic and Reproductive Medicine', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Dexeus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Gamete and Embryo Donation', 'investigatorFullName': 'Elisabet Clua Obrado', 'investigatorAffiliation': 'Fundacion Dexeus'}}}}