Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 2:15 AM
Study NCT ID:
NCT01219504
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2010-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples on female and male patients. Buccal swabs on infant(s).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of biopsy on pregnancy', 'timeFrame': '1 year', 'description': 'Impact of the biopsy of the embryo on whether a pregnancy is obtained'}, {'measure': 'Impact of biopsy on delivery', 'timeFrame': '1 year', 'description': 'Impact of the biopsy on pregnancy resulting in delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PGD', 'IVF'], 'conditions': ['Each Patient is Both Case and Control', '1 Embryo Will be Biopsied and 1 Embryo is Not']}, 'referencesModule': {'references': [{'pmid': '23773313', 'type': 'DERIVED', 'citation': 'Scott RT Jr, Upham KM, Forman EJ, Zhao T, Treff NR. Cleavage-stage biopsy significantly impairs human embryonic implantation potential while blastocyst biopsy does not: a randomized and paired clinical trial. Fertil Steril. 2013 Sep;100(3):624-30. doi: 10.1016/j.fertnstert.2013.04.039. Epub 2013 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'To assess the impact of embryo biopsy on the reproductive potential of human embryos.', 'detailedDescription': 'This study will recruit patients from the NY/NJ/CT/eastern PA area only.\n\nAll patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.\n\nOn day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.\n\nFollowing delivery, buccal swabs will be collected from infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 infertile couples undergoing IVF will be enrolled in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'This study will recruit patients from the NY/NJ/CT/eastern PA area only.\n\nInclusion Criteria:\n\n1. Maximum of one prior failed IVF treatment cycle\n2. Female partner less than 35 years of age\n3. Normal day 3 FSH level (\\<10 miu/mL)\n4. Total basal antral follicle count greater than or equal to 12\n5. Male partner with greater than 100,000 total motile spermatozoa and at least 1% normal forms\n6. Body mass index (BMI) \\< or = 32\n7. Normal uterine cavity\n\nExclusion Criteria:\n\n1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease\n2. Diagnosis of endometrial insufficiency\n3. Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with PGD to rule out a known genetic defect)\n4. Use of testicular aspiration or biopsy procedures to obtain sperm'}, 'identificationModule': {'nctId': 'NCT01219504', 'briefTitle': 'Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF', 'orgStudyIdInfo': {'id': 'RMA-00-17'}}, 'contactsLocationsModule': {'locations': [{'zip': '06850', 'city': 'Norfolk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Reproductive Medicine Associates of Connecticut', 'geoPoint': {'lat': 41.99398, 'lon': -73.20206}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Reproductive Medicine Associates of New Jersey', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10022', 'city': 'New York', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Reproductive Medicine Associates of New York'}], 'overallOfficials': [{'name': 'Richard T Scott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medicine Associates of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}