Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia

NCT06564961 | Completed Phase 3

• 1 other identifier: 4068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Does drug clomiphene citrate change sperm count and motility in infertile men with idiopathic oligoasthenozoospermia?
• 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.

Conditions

Infertility, Male

Keywords

Male infertility; Oligoasthenozoospermia; Testosterone; Clomiphene citrate

Outcome Measures

Primary Outcomes (2)

• Change from baseline in sperm motility at 12 weeks

  Sperm motility was percentage of progressive \& non-progressive motility

  Baseline and 12 weeks

• Change from baseline in sperm count at 12 weeks

  Sperm count was in million per milliliter of semen

  Baseline and 12 weeks

Study Arms (2)

Clomiphene

EXPERIMENTAL

Participants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks

Drug: Clomiphene Citrate

Placebo

PLACEBO COMPARATOR

Participants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks

Drug: Placebo

Interventions

Clomiphene Citrate DRUG

50 mg tab once daily

Also known as: Tab OVULET (Renata Pharmaceuticals Limited)

Clomiphene

Placebo DRUG

1 tab once daily

Also known as: Placebo provided by Renata Pharmaceuticals Limited

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile men
• Idiopathic oligoasthenozoospermia (serum FSH and serum LH range was 2-7 IU/mL and serum testosterone level was \>300 ng/dl)

You may not qualify if:

• Azoospermia
• Body mass index \<18 kg/m2 and \>30 kg/m2
• Any abnormality on genital examination and scrotal sonogram
• History of genital diseases \& genital surgery
• Medical and endocrine disorders like uncontrolled diabetes mellitus, severe kidney disease and liver insufficiency
• Psycho-sexual abnormalities
• Antioxidant supplements in previous 3 months
• Smoking, drug, alcohol or substance abuse
• History of chemotherapy or radiotherapy
• Presence of any gross female factor abnormality

Sponsors & Collaborators

• Shakeela Ishrat: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1200, Bangladesh

Location

Related Publications (7)

• 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: 25660648 BACKGROUND

• 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: 25309854 BACKGROUND

• Cocuzza M, Agarwal A. Nonsurgical treatment of male infertility: specific and empiric therapy. Biologics. 2007 Sep;1(3):259-69.

  PMID: 19707335 BACKGROUND

• 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: 23970453 BACKGROUND

• 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: 37559276 BACKGROUND

• 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: 36680549 BACKGROUND

• 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.

  PMID: 26235968 RESULT

MeSH Terms

Conditions

Infertility, Male

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: July 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)