Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-30 @ 1:48 PM
Study NCT ID:
NCT01267604
Status:
WITHDRAWN
Last Update Posted:
2023-07-20
First Post:
2010-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Stimulation: Inositol and Melatonin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007294', 'term': 'Inositol'}, {'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2010-12-23', 'studyFirstSubmitQcDate': '2010-12-27', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total oocyte number', 'timeFrame': '2 weeks after pharmacological treatment'}, {'measure': 'Number of clinical pregnancies', 'timeFrame': '6 weeks after embryo transfer'}, {'measure': 'Live birth rate', 'timeFrame': '10 months after embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '20712264', 'type': 'BACKGROUND', 'citation': 'Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.'}, {'pmid': '19800728', 'type': 'BACKGROUND', 'citation': 'Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.'}, {'pmid': '18804205', 'type': 'BACKGROUND', 'citation': 'Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18.'}]}, 'descriptionModule': {'briefSummary': 'An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.\n\nRecent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).\n\nTo this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.\n\nAs primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female age 18-39 years\n* BMI 18-30 kg/m2,\n* Fewer than 3 prior oocyte retrievals,\n* No fertility Problems'}, 'identificationModule': {'nctId': 'NCT01267604', 'briefTitle': 'Ovarian Stimulation: Inositol and Melatonin', 'organization': {'class': 'OTHER', 'fullName': 'AGUNCO Obstetrics and Gynecology Centre'}, 'officialTitle': 'Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin', 'orgStudyIdInfo': {'id': 'rFSH-INOPLUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant FSH', 'description': '225IU rFSH', 'interventionNames': ['Drug: Recombinant FSH (rFSH)']}, {'type': 'EXPERIMENTAL', 'label': 'Recombinant FSH Inositol Melatonin', 'description': '225IU rFSH, 4g Inositol and 3mg Melatonin', 'interventionNames': ['Dietary Supplement: rFSH + Inositol + Melatonin']}], 'interventions': [{'name': 'Recombinant FSH (rFSH)', 'type': 'DRUG', 'description': '225IU', 'armGroupLabels': ['Recombinant FSH']}, {'name': 'rFSH + Inositol + Melatonin', 'type': 'DIETARY_SUPPLEMENT', 'description': '225IU rFSH, 4g Inositol, 3mg Melatonin', 'armGroupLabels': ['Recombinant FSH Inositol Melatonin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'University of Modena and Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00199', 'city': 'Roma', 'country': 'Italy', 'facility': 'Research Center for Reproductive Medicine Villa Mafalda', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Vittorio Unfer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AGUNCO Obstetrics and Gynecology Centre'}, {'name': 'Gianfranco Carlomagno, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AGUNCO Obstetrics and Gynecology Centre'}, {'name': 'La Sala Giovanni Battista, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Modena and Reggio Emilia'}, {'name': 'Franco Lisi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Reproductive Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGUNCO Obstetrics and Gynecology Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, {'name': 'Research Center for Reproductive Medicine Villa Mafalda', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}