Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-26 @ 11:14 AM
Study NCT ID:
NCT02275169
Status:
UNKNOWN
Last Update Posted:
2015-02-02
First Post:
2014-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FSH Treatment for Non-obstructive Azoospermic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053713', 'term': 'Azoospermia'}, {'id': 'C564665', 'term': 'Azoospermia, Nonobstructive'}, {'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050477', 'term': 'Urofollitropin'}], 'ancestors': [{'id': 'D008596', 'term': 'Menotropins'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-30', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm retrieval rate (SRR)', 'timeFrame': 'three months', 'description': 'testicular sperm retrieval rate after three months of urofollitropin treatment'}], 'secondaryOutcomes': [{'measure': 'IVF pregnancy rate', 'timeFrame': 'three to six months'}, {'measure': 'IVF implantation rate', 'timeFrame': 'three to six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['follicle stimulating hormone treatment', 'azoospermia nonobstructive', 'male infertility', 'follicle stimulating hormone'], 'conditions': ['Azoospermia']}, 'referencesModule': {'references': [{'pmid': '18423236', 'type': 'BACKGROUND', 'citation': 'Sussman EM, Chudnovsky A, Niederberger CS. Hormonal evaluation of the infertile male: has it evolved? Urol Clin North Am. 2008 May;35(2):147-55, vii. doi: 10.1016/j.ucl.2008.01.010.'}, {'pmid': '11743304', 'type': 'BACKGROUND', 'citation': 'Schoor RA, Elhanbly S, Niederberger CS, Ross LS. The role of testicular biopsy in the modern management of male infertility. J Urol. 2002 Jan;167(1):197-200.'}, {'pmid': '14667875', 'type': 'RESULT', 'citation': "Caroppo E, Niederberger C, Vizziello GM, D'Amato G. Recombinant human follicle-stimulating hormone as a pretreatment for idiopathic oligoasthenoteratozoospermic patients undergoing intracytoplasmic sperm injection. Fertil Steril. 2003 Dec;80(6):1398-403. doi: 10.1016/s0015-0282(03)02202-7."}, {'pmid': '24919724', 'type': 'RESULT', 'citation': 'Kato Y, Shiraishi K, Matsuyama H. Expression of testicular androgen receptor in non-obstructive azoospermia and its change after hormonal therapy. Andrology. 2014 Sep;2(5):734-40. doi: 10.1111/j.2047-2927.2014.00240.x. Epub 2014 Jun 12.'}, {'pmid': '22958644', 'type': 'RESULT', 'citation': 'Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.', 'detailedDescription': 'Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA, but no RCT are available in the field. This randomized placebo-controlled clinical trial sought to evaluate whether the testicular sperm retrieval rate could result higher in NOA patients treated with follicle-stimulating hormone compared to placebo-treated NOA subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Azoospermia;\n* testis longitudinal axis less than 4.5 cm;\n* serum follicle-stimulating hormone greater than 7.6 IU/L\n\nExclusion Criteria:\n\n* History of testicular biopsy,\n* malignancy,\n* varicocele,\n* hyperprolactinemia,\n* thyroid disfunction,\n* chemotherapy,\n* radiotherapy'}, 'identificationModule': {'nctId': 'NCT02275169', 'briefTitle': 'FSH Treatment for Non-obstructive Azoospermic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria Locale Bari'}, 'officialTitle': 'Follicle-stimulating Hormone Treatment for Infertile Male Patients With Non-obstructive Azoospermia: a Multicenter Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ASLBari'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated', 'description': 'Urofollitropin 150 IU ampoules three times a week for three months', 'interventionNames': ['Drug: Urofollitropin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Controls', 'description': 'Placebo ampoules three times a week for three months', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Urofollitropin', 'type': 'DRUG', 'otherNames': ['Fostimon'], 'description': 'Urofollitropin 75 IU 2 ampoules three times a week for three months', 'armGroupLabels': ['Treated']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo ampoules administered three times a week for three months', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ettore Caroppo, MD', 'role': 'CONTACT', 'email': 'ecaroppo@teseo.it', 'phone': '+393479103660'}, {'name': 'Craig Niederberger, MD', 'role': 'CONTACT', 'email': 'craignied@gmail.com', 'phone': '3129969330'}], 'overallOfficials': [{'name': 'Ettore Caroppo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ASL Bari'}, {'name': 'Craig Niederberger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University at Illinois at Chicago UIC College of Medicine'}, {'name': 'Alayman Hussein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'El Minia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria Locale Bari', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ettore Caroppo', 'investigatorAffiliation': 'Azienda Sanitaria Locale Bari'}}}}