Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01843569
Status:
WITHDRAWN
Last Update Posted:
2020-11-16
First Post:
2013-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Vitro Maturation (IVM) of Human Oocytes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059471', 'term': 'In Vitro Oocyte Maturation Techniques'}], 'ancestors': [{'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Institutional approval of study has expired.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-12', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy', 'timeFrame': '1 month', 'description': 'Establishment of a successful pregnancy'}, {'measure': 'Implantation', 'timeFrame': '1 month', 'description': 'fetal hearts per embryo replaced'}, {'measure': 'live birth rates', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Multiple pregnancy and miscarriage rates', 'timeFrame': '9 months'}, {'measure': 'Neonatal outcomes', 'timeFrame': '9 months'}, {'measure': 'Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])', 'timeFrame': '2 weeks'}, {'measure': 'Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment', 'timeFrame': '2 weeks'}, {'measure': 'Number and quality of oocytes retrieved', 'timeFrame': '1 day'}, {'measure': 'Oocyte maturation rate', 'timeFrame': '1 week'}, {'measure': 'Number of fertilized oocytes', 'timeFrame': '2 days'}, {'measure': 'Fertilization rate', 'timeFrame': '1 day'}, {'measure': 'Number and quality of embryos generated', 'timeFrame': '1 week'}, {'measure': 'Endometrial thickness', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['In Vitro Maturation', 'IVM', 'Natural cycle IVF', 'PCOS'], 'conditions': ['Polycystic Ovarian Syndrome (PCOS)', 'Patients Sensitive to Exogenous Gonadotropins', 'Ovarian Hyper Stimulation Syndrome (OHSS)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Practice Committee of the American Society for Reproductive Medicine (ASRM). Committee opinion: In Vitro Maturation. Fertil & Steril. Ready for member review 2/21/12. Not yet in print.'}, {'pmid': '15528263', 'type': 'BACKGROUND', 'citation': 'Le Du A, Kadoch IJ, Bourcigaux N, Doumerc S, Bourrier MC, Chevalier N, Fanchin R, Chian RC, Tachdjian G, Frydman R, Frydman N. In vitro oocyte maturation for the treatment of infertility associated with polycystic ovarian syndrome: the French experience. Hum Reprod. 2005 Feb;20(2):420-4. doi: 10.1093/humrep/deh603. Epub 2004 Nov 4.'}, {'pmid': '14989791', 'type': 'BACKGROUND', 'citation': 'Chian RC, Buckett WM, Tan SL. In-vitro maturation of human oocytes. Reprod Biomed Online. 2004 Feb;8(2):148-66. doi: 10.1016/s1472-6483(10)60511-1.'}, {'pmid': '16996508', 'type': 'BACKGROUND', 'citation': 'Jurema MW, Nogueira D. In vitro maturation of human oocytes for assisted reproduction. Fertil Steril. 2006 Nov;86(5):1277-91. doi: 10.1016/j.fertnstert.2006.02.126. Epub 2006 Sep 25.'}, {'pmid': '17906024', 'type': 'BACKGROUND', 'citation': 'Buckett WM, Chian RC, Holzer H, Dean N, Usher R, Tan SL. Obstetric outcomes and congenital abnormalities after in vitro maturation, in vitro fertilization, and intracytoplasmic sperm injection. Obstet Gynecol. 2007 Oct;110(4):885-91. doi: 10.1097/01.AOG.0000284627.38540.80.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk of ovarian hyperstimulation syndrome.', 'detailedDescription': 'Natural IVF/IVM may be an attractive treatment alternative to conventional controlled ovarian hyperstimulation (COH)/IVF treatment for infertile women in particular for a select group.\n\nNatural IVF/IVM offers several advantages over conventional COH protocols for IVF including:\n\n1. Elimination of the need for gonadotropin ovarian stimulation\n2. Elimination of risk of developing OHSS\n3. Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring\n4. Reduced cost of treatment\n5. Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings\n6. Eliminates concerns about the potential risk of malignancy that may be associated with multiple cycles of ovarian stimulation in a predisposed population.\n\nThis pilot study will be conducted to assess the clinical efficacy of natural IVF/IVM'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Each subject must be female.\n2. Each subject must have an indication for COH and IVF or ICSI.\n3. Each subject must be willing and able to provide written informed consent for the trial.\n4. Each subject must be ≤42 years of age at the time of signing informed consent.\n5. Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou \\[PAP\\] I or II) obtained within 12 months prior to signing informed consent must be available.\n\nExclusion Criteria:\n\n1. Subject with premature ovarian failure.\n2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction.\n3. Subject with malformation or absence of uterus.\n4. Subject tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).\n5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone.'}, 'identificationModule': {'nctId': 'NCT01843569', 'acronym': 'IVM', 'briefTitle': 'In Vitro Maturation (IVM) of Human Oocytes', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'In Vitro Maturation (IVM) of Human Oocytes', 'orgStudyIdInfo': {'id': '12-364A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVM', 'description': 'All patients registered in this study will undergo natural cycle IVF with In Vitro maturation (IVM) performed on all immature retrieved oocytes.', 'interventionNames': ['Biological: In Vitro maturation']}], 'interventions': [{'name': 'In Vitro maturation', 'type': 'BIOLOGICAL', 'armGroupLabels': ['IVM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Human Reproduction', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}], 'overallOfficials': [{'name': 'Avner Hershlag, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NSLIJ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}