Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 1:56 PM
Study NCT ID:
NCT01343992
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bed Rest or no Bed Rest?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001510', 'term': 'Bed Rest'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-22', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth infant rate after delivery from both groups of study', 'timeFrame': '10 months', 'description': 'Whether bed rest after embryo transfer affects the pregnancy rate in IVF treatment with oocyte donation.'}], 'secondaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '2 months'}, {'measure': 'Miscarriage rate', 'timeFrame': '5 months'}, {'measure': 'Birth weight of live newborn infant after delivery', 'timeFrame': '10 months'}, {'measure': 'Birth height of live newborn infant after delivery', 'timeFrame': '10 months'}, {'measure': 'Cranial perimeter of live newborn infant after delivery', 'timeFrame': '10 months'}, {'measure': 'APGAR score of live newborn infant after delivery', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Embryo transfer', 'Implantation rate', 'Pregnancy rate', 'bedrest', 'neutral', 'benevolent', 'deterious', 'implantation', 'gestation rates'], 'conditions': ['In Vitro Fertilization']}, 'referencesModule': {'references': [{'pmid': '23755954', 'type': 'DERIVED', 'citation': 'Gaikwad S, Garrido N, Cobo A, Pellicer A, Remohi J. Bed rest after embryo transfer negatively affects in vitro fertilization: a randomized controlled clinical trial. Fertil Steril. 2013 Sep;100(3):729-35. doi: 10.1016/j.fertnstert.2013.05.011. Epub 2013 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'A comparative study to determine whether bed rest after embryo transfer (ET) affects on IVF (In Vitro Fertilization)outcome. This study includes 240 patients undergoing IVF treatment with donated oocytes. All the procedures of IVF, of the embryo transfer, and of the administration of medications are performed as always and there are no variations. The only highlighted procedure in this study is immediately after the embryo transfer. There are two groups: one which will rest in bed for 10 minutes after the transfer and one which will not rest after the transfer. Both procedures are common, usually depending on the habitual clinical practice of each clinic internationally. Patients from both group receive the routine post transfer instructions and treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Infertile Patients with fertility problems due to tubaric or ovarian problems with normozoospermatic couple\n* Patient and her couple with ages between ages 20 - 49 years old\n* BMI \\< 25 kg/m2\n* IVF treatment with oocyte donation\n* Elective transfer of 2 embryos of day 3 embryos or day 5/6 embryos transferred\n* First cycle of embryo transfer\n\nExclusion criteria:\n\n* Patients with uterine abnormalities, significant uterine fibroids, Hydrosalphinx\n* History of recurrent pregnancy loss\n* severe male factor were excluded from the study'}, 'identificationModule': {'nctId': 'NCT01343992', 'briefTitle': 'Bed Rest or no Bed Rest?', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}, 'officialTitle': 'Evaluation of the Influence of Bed Rest After Embryo Transfer in Outcome of IVF Treatment With Ovum Donation.', 'orgStudyIdInfo': {'id': '0912-C-065-SA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bedrest', 'description': 'Patients will rest in bed ten minutes after the embryo transfer.', 'interventionNames': ['Behavioral: Bed rest']}, {'type': 'EXPERIMENTAL', 'label': 'No bed rest', 'description': 'Patients will not rest after the embryo transfer.', 'interventionNames': ['Behavioral: No bedrest']}], 'interventions': [{'name': 'Bed rest', 'type': 'BEHAVIORAL', 'description': 'Patients will rest in bed ten minutes after the embryo transfer.', 'armGroupLabels': ['Bedrest']}, {'name': 'No bedrest', 'type': 'BEHAVIORAL', 'description': 'Patients will not rest in bed after the embryo transfer.', 'armGroupLabels': ['No bed rest']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46117', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Infertilidad', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Dr. Sharayi Gaikwad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Valenciano de Infertilidad'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Valenciano de Infertilidad, IVI VALENCIA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologist IVI Valencia', 'investigatorFullName': 'Jose Remohi', 'investigatorAffiliation': 'Instituto Valenciano de Infertilidad, IVI VALENCIA'}}}}