Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-01 @ 8:38 PM
Study NCT ID:
NCT01268592
Status:
TERMINATED
Last Update Posted:
2013-04-23
First Post:
2010-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fertility Preservation in Female Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Study technique has been declared part of standard care', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-22', 'studyFirstSubmitDate': '2010-11-01', 'studyFirstSubmitQcDate': '2010-12-29', 'lastUpdatePostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'successful pregnancy', 'timeFrame': 'nine months after transfer of embryo(s)', 'description': 'the primary objective of this study is the establishment of a successful pregnancy, following a disease-free interval after treatment for her cancer; this interval will be patient-dependent and will undoubtedly vary between participants.'}], 'secondaryOutcomes': [{'measure': 'impact of stimulation on cancer recurrence', 'timeFrame': '5 years after treatment', 'description': 'patients will be followed for five years following cancer treatment to assess the risks associated with ovarian stimulation and the recurrence of cancer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fertility preservation', 'oocyte cryopreservation', 'vitrification', 'egg freezing', 'fertility preservation in female cancer patients'], 'conditions': ['Fertility']}, 'referencesModule': {'references': [{'pmid': '20379357', 'type': 'BACKGROUND', 'citation': 'Ajala T, Rafi J, Larsen-Disney P, Howell R. Fertility preservation for cancer patients: a review. Obstet Gynecol Int. 2010;2010:160386. doi: 10.1155/2010/160386. Epub 2010 Mar 31.'}, {'pmid': '18509175', 'type': 'BACKGROUND', 'citation': 'Azim AA, Costantini-Ferrando M, Oktay K. Safety of fertility preservation by ovarian stimulation with letrozole and gonadotropins in patients with breast cancer: a prospective controlled study. J Clin Oncol. 2008 Jun 1;26(16):2630-5. doi: 10.1200/JCO.2007.14.8700.'}, {'pmid': '17356042', 'type': 'BACKGROUND', 'citation': 'Azim AA, Costantini-Ferrando M, Lostritto K, Oktay K. Relative potencies of anastrozole and letrozole to suppress estradiol in breast cancer patients undergoing ovarian stimulation before in vitro fertilization. J Clin Endocrinol Metab. 2007 Jun;92(6):2197-200. doi: 10.1210/jc.2007-0247. Epub 2007 Mar 13.'}, {'pmid': '10401494', 'type': 'BACKGROUND', 'citation': 'Blatt J. Pregnancy outcome in long-term survivors of childhood cancer. Med Pediatr Oncol. 1999 Jul;33(1):29-33. doi: 10.1002/(sici)1096-911x(199907)33:13.0.co;2-2.'}, {'pmid': '15950628', 'type': 'BACKGROUND', 'citation': 'Ethics Committee of the American Society for Reproductive Medicine. Fertility preservation and reproduction in cancer patients. Fertil Steril. 2005 Jun;83(6):1622-8. doi: 10.1016/j.fertnstert.2005.03.013.'}, {'pmid': '16414339', 'type': 'BACKGROUND', 'citation': 'Ganz PA. Breast cancer, menopause, and long-term survivorship: critical issues for the 21st century. Am J Med. 2005 Dec 19;118 Suppl 12B:136-41. doi: 10.1016/j.amjmed.2005.09.047.'}, {'pmid': '17846105', 'type': 'BACKGROUND', 'citation': 'Gook DA, Edgar DH. Human oocyte cryopreservation. Hum Reprod Update. 2007 Nov-Dec;13(6):591-605. doi: 10.1093/humupd/dmm028. Epub 2007 Sep 10.'}, {'pmid': '19439285', 'type': 'BACKGROUND', 'citation': 'Grifo JA, Noyes N. Delivery rate using cryopreserved oocytes is comparable to conventional in vitro fertilization using fresh oocytes: potential fertility preservation for female cancer patients. Fertil Steril. 2010 Feb;93(2):391-6. doi: 10.1016/j.fertnstert.2009.02.067. Epub 2009 May 12.'}, {'pmid': '19246362', 'type': 'BACKGROUND', 'citation': 'Jeruss JS, Woodruff TK. Preservation of fertility in patients with cancer. N Engl J Med. 2009 Feb 26;360(9):902-11. doi: 10.1056/NEJMra0801454. No abstract available.'}, {'pmid': '18804204', 'type': 'BACKGROUND', 'citation': 'Knopman JM, Noyes N, Talebian S, Krey LC, Grifo JA, Licciardi F. Women with cancer undergoing ART for fertility preservation: a cohort study of their response to exogenous gonadotropins. Fertil Steril. 2009 Apr;91(4 Suppl):1476-8. doi: 10.1016/j.fertnstert.2008.07.1727. Epub 2008 Sep 18.'}, {'pmid': '19013563', 'type': 'BACKGROUND', 'citation': 'Quintero RB, Helmer A, Huang JQ, Westphal LM. Ovarian stimulation for fertility preservation in patients with cancer. Fertil Steril. 2010 Feb;93(3):865-8. doi: 10.1016/j.fertnstert.2008.10.007. Epub 2008 Nov 14.'}, {'type': 'BACKGROUND', 'citation': 'Kumayama M and Kato O. All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447, 2000.'}, {'type': 'BACKGROUND', 'citation': 'Nagy ZP, Chang CC, Bernal DP, Shapiro D, Mitchell-Leef D and Kort HI. Comparison of laboratory and clinical outcomes between fresh and vitrified sibling oocytes obtained from 30-39 year old IVF patients. Fertil Steril 92, Supp3:S67, 2009.'}, {'pmid': '18692830', 'type': 'BACKGROUND', 'citation': 'Nagy ZP, Chang CC, Shapiro DB, Bernal DP, Elsner CW, Mitchell-Leef D, Toledo AA, Kort HI. Clinical evaluation of the efficiency of an oocyte donation program using egg cryo-banking. Fertil Steril. 2009 Aug;92(2):520-6. doi: 10.1016/j.fertnstert.2008.06.005. Epub 2008 Aug 9.'}, {'pmid': '20140641', 'type': 'BACKGROUND', 'citation': 'Noyes N, Boldt J, Nagy ZP. Oocyte cryopreservation: is it time to remove its experimental label? J Assist Reprod Genet. 2010 Feb;27(2-3):69-74. doi: 10.1007/s10815-009-9382-y. Epub 2010 Feb 6.'}, {'pmid': '16882752', 'type': 'BACKGROUND', 'citation': 'Oktay K, Hourvitz A, Sahin G, Oktem O, Safro B, Cil A, Bang H. Letrozole reduces estrogen and gonadotropin exposure in women with breast cancer undergoing ovarian stimulation before chemotherapy. J Clin Endocrinol Metab. 2006 Oct;91(10):3885-90. doi: 10.1210/jc.2006-0962. Epub 2006 Aug 1.'}, {'pmid': '18971682', 'type': 'BACKGROUND', 'citation': 'Porcu E, Bazzocchi A, Notarangelo L, Paradisi R, Landolfo C, Venturoli S. Human oocyte cryopreservation in infertility and oncology. Curr Opin Endocrinol Diabetes Obes. 2008 Dec;15(6):529-35. doi: 10.1097/MED.0b013e3283199129.'}, {'pmid': '23083924', 'type': 'BACKGROUND', 'citation': 'Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013 Jan;99(1):37-43. doi: 10.1016/j.fertnstert.2012.09.028. Epub 2012 Oct 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to preserve the fertility potential in females diagnosed with cancer by vitrifying (rapidly freezing) their oocytes (eggs) before undergoing treatment for their cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '42 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must be 14-42 year old females with a cancer diagnosis.\n* Clearance letter from treating oncologist.\n* Approval by program oncologist or her designee.\n* Informed consent has to be signed after consultation with the program physician. Minors require consent of a parent or a legal guardian and assent from the participant.\n* Life expectancy (predicted by their malignancy) of 5 or more years.\n* Cancer diagnosis should have an expected cure rate of 50% or more, based upon clinico-pathologic features.\n\nExclusion Criteria:\n\n* Patients whose oncologist and the program oncologist concur that immediate oncologic care should be rendered, not allowing sufficient time for a course of gonadotropin therapy and egg retrieval.\n* FSH level \\>20 MIU/ml, indicating abnormal ovarian function.\n* Patients with stage IV cancers (\\*age appropriate women with stage IV advanced Hodgkin's Lymphoma will be considered, as there is a significant long term survival rate with this advanced disease).\n* Patients with incurable cancer diagnoses.\n* Patients who are unable or unwilling to sign the informed consent.\n* Women cannot have an embryo transfer beyond age 50."}, 'identificationModule': {'nctId': 'NCT01268592', 'briefTitle': 'Fertility Preservation in Female Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential', 'orgStudyIdInfo': {'id': '10-204A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'positive cancer diagnosis', 'description': 'female patients diagnosed with cancer who wish to preserve their fertility by vitrifying their oocytes', 'interventionNames': ['Procedure: oocyte vitrification']}], 'interventions': [{'name': 'oocyte vitrification', 'type': 'PROCEDURE', 'description': "freezing of the patient's retrieved oocytes via vitrification (rapid freezing)", 'armGroupLabels': ['positive cancer diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Human Reproduction', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Avner Hershlag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Human Reproduction'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}