Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-02-05 @ 5:55 PM
Study NCT ID:
NCT06564961
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2024-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D002996', 'term': 'Clomiphene'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-19', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in sperm motility at 12 weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Sperm motility was percentage of progressive \\& non-progressive motility'}, {'measure': 'Change from baseline in sperm count at 12 weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Sperm count was in million per milliliter of semen'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male infertility', 'Oligoasthenozoospermia', 'Testosterone', 'Clomiphene citrate'], 'conditions': ['Infertility, Male']}, 'referencesModule': {'references': [{'pmid': '25660648', 'type': 'BACKGROUND', 'citation': 'Chehab M, Madala A, Trussell JC. On-label and off-label drugs used in the treatment of male infertility. Fertil Steril. 2015 Mar;103(3):595-604. doi: 10.1016/j.fertnstert.2014.12.122. Epub 2015 Feb 3.'}, {'pmid': '25309854', 'type': 'BACKGROUND', 'citation': 'Jung JH, Seo JT. Empirical medical therapy in idiopathic male infertility: Promise or panacea? Clin Exp Reprod Med. 2014 Sep;41(3):108-14. doi: 10.5653/cerm.2014.41.3.108. Epub 2014 Sep 30.'}, {'pmid': '19707335', 'type': 'BACKGROUND', 'citation': 'Cocuzza M, Agarwal A. Nonsurgical treatment of male infertility: specific and empiric therapy. Biologics. 2007 Sep;1(3):259-69.'}, {'pmid': '23970453', 'type': 'BACKGROUND', 'citation': 'Chua ME, Escusa KG, Luna S, Tapia LC, Dofitas B, Morales M. Revisiting oestrogen antagonists (clomiphene or tamoxifen) as medical empiric therapy for idiopathic male infertility: a meta-analysis. Andrology. 2013 Sep;1(5):749-57. doi: 10.1111/j.2047-2927.2013.00107.x.'}, {'pmid': '37559276', 'type': 'BACKGROUND', 'citation': 'Bridges N, Trofimenko V, Fields S, Carrell D, Aston K, Hotaling J. Male Factor Infertility and Clomiphene Citrate: A Meta-Analysis-The Effect of Clomiphene Citrate on Oligospermia. Urol Pract. 2015 Jul;2(4):199-205. doi: 10.1016/j.urpr.2014.10.007. Epub 2015 Apr 10.'}, {'pmid': '36680549', 'type': 'BACKGROUND', 'citation': 'Huijben M, Huijsmans RLN, Lock MTWT, de Kemp VF, de Kort LMO, van Breda JHMK. Clomiphene citrate for male infertility: A systematic review and meta-analysis. Andrology. 2023 Sep;11(6):987-996. doi: 10.1111/andr.13388. Epub 2023 Jan 29.'}, {'pmid': '26235968', 'type': 'RESULT', 'citation': 'ElSheikh MG, Hosny MB, Elshenoufy A, Elghamrawi H, Fayad A, Abdelrahman S. Combination of vitamin E and clomiphene citrate in treating patients with idiopathic oligoasthenozoospermia: A prospective, randomized trial. Andrology. 2015 Sep;3(5):864-7. doi: 10.1111/andr.12086. Epub 2015 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if drug clomiphene citrate improves sperm parameters in infertile men with idiopathic oligoasthenozoospermia. It will also learn about the safety of clomiphene citrate. The main questions it aims to answer are:\n\n* Does drug clomiphene citrate change sperm count and motility in infertile men with idiopathic oligoasthenozoospermia?\n* What medical problems do participants have when taking drug clomiphene citrate? Researchers will compare drug clomiphene citrate to a placebo (a look-alike substance that contains no drug) to see if drug clomiphene citrate works to treat idiopathic oligoasthenozoospermia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile men\n* Idiopathic oligoasthenozoospermia (serum FSH and serum LH range was 2-7 IU/mL and serum testosterone level was \\>300 ng/dl)\n\nExclusion Criteria:\n\n* Azoospermia\n* Body mass index \\<18 kg/m2 and \\>30 kg/m2\n* Any abnormality on genital examination and scrotal sonogram\n* History of genital diseases \\& genital surgery\n* Medical and endocrine disorders like uncontrolled diabetes mellitus, severe kidney disease and liver insufficiency\n* Psycho-sexual abnormalities\n* Antioxidant supplements in previous 3 months\n* Smoking, drug, alcohol or substance abuse\n* History of chemotherapy or radiotherapy\n* Presence of any gross female factor abnormality'}, 'identificationModule': {'nctId': 'NCT06564961', 'briefTitle': 'Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'The Effect of Clomiphene Citrate on Sperm Parameters in Infertile Men With Idiopathic Oligoasthenozoospermia', 'orgStudyIdInfo': {'id': '4068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clomiphene', 'description': 'Participants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks', 'interventionNames': ['Drug: Clomiphene Citrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clomiphene Citrate', 'type': 'DRUG', 'otherNames': ['Tab OVULET (Renata Pharmaceuticals Limited)'], 'description': '50 mg tab once daily', 'armGroupLabels': ['Clomiphene']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo provided by Renata Pharmaceuticals Limited'], 'description': '1 tab once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Bangabandhu Sheikh Mujib Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shakeela Ishrat', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shakeela Ishrat', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}