Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-21 @ 12:18 AM
Study NCT ID:
NCT01532193
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2012-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Embryo Culture Under Low Oxygen Tension on Pregnancy Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 380}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2012-02-09', 'studyFirstSubmitQcDate': '2012-02-13', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rates per cycle', 'timeFrame': 'one month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Oxygen Tension']}, 'referencesModule': {'references': [{'pmid': '32772073', 'type': 'DERIVED', 'citation': 'Rendon Abad M, Serra V, Gamiz P, de Los Santos JM, Remohi J, Navarro AT, de Los Santos MJ. The influence of oxygen concentration during embryo culture on obstetric and neonatal outcomes: a secondary analysis of a randomized controlled trial. Hum Reprod. 2020 Sep 1;35(9):2017-2025. doi: 10.1093/humrep/deaa152.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether the use of low oxygen tension during "in vitro" embryo culture may increase the pregnancy rates in women undergoing egg donation.', 'detailedDescription': 'As far as oxygen (O2) tension is concerned, both oocytes and embryos from different mammalian species included the human are normally surrounded by values which are much less than half of atmospheric O2, ranging from high (8.7% O2) in the rabbit oviduct, rabbit and hamster uterus, to as low as 11 mm Hg (1.5% O2) in the monkey uterus. Even in the preovulatory follicle, oocytes are bathed within follicular fluids containing oxygen that range from \\> 1 to 5.5 % The aim of this study was to evaluate the impact the effect of low oxygen tension after day-3 embryo transfer in our egg donation programme on pregnancy and implantation rates.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 25-45 years of age;\n* In good mental and physical health;\n* First or second of egg-recipient treatment;\n* Embryo transfer on Day 3.\n* One to three embryos will be transferred.\n* BMI between 18-25 kg/m2.\n\nExclusion Criteria:\n\n* Uterine pathology or hydrosalpinx\n* Recurrent miscarriage\n* No chronic illnesses'}, 'identificationModule': {'nctId': 'NCT01532193', 'briefTitle': 'The Effect of Embryo Culture Under Low Oxygen Tension on Pregnancy Rates', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'A Randomized Controlled Trial Evaluation the Effect of Low Oxygen Tension on the Pregnancy Rate After Day 3 Embryo Transfer in an Egg Donation Programme.', 'orgStudyIdInfo': {'id': '0903-C-059-MJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hipoxia', 'description': 'The low oxygen tension group', 'interventionNames': ['Other: Decreased oxygen concentration']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Conventional culture conditions'}], 'interventions': [{'name': 'Decreased oxygen concentration', 'type': 'OTHER', 'description': 'The oxygen concentration is decreased during the "in Vitro" embryo culture.', 'armGroupLabels': ['Hipoxia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46015', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Ivi Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Maria Jose Delossantos', 'investigatorFullName': 'Maria Jose Delossantos', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}