Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia

Phase 3

Completed

• Conditions: Infertility, Male
• Interventions: Drug: Placebo; Drug: Clomiphene Citrate

• Registration Number: NCT06564961
• Lead Sponsor: Shakeela Ishrat

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31
• Status Verified: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks
Clomiphene	Clomiphene Citrate	Participants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in sperm motility at 12 weeks	Baseline and 12 weeks	Sperm motility was percentage of progressive \& non-progressive motility
Change from baseline in sperm count at 12 weeks	Baseline and 12 weeks	Sperm count was in million per milliliter of semen

Trial Locations

Locations (1)

Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Bangladesh