Skip to main content
OpenTrials
Completed

NCT Number: NCT06564961

Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

25 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1200, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clomiphene Citrate

Drug

50 mg tab once daily

Other names: Tab OVULET (Renata Pharmaceuticals Limited)

Placebo

Drug

1 tab once daily

Other names: Placebo provided by Renata Pharmaceuticals Limited

Primary outcomes

  1. Change from baseline in sperm motility at 12 weeks

    Time frame: Baseline and 12 weeks

    Sperm motility was percentage of progressive & non-progressive motility

  2. Change from baseline in sperm count at 12 weeks

    Time frame: Baseline and 12 weeks

    Sperm count was in million per milliliter of semen

Sponsors and collaborators

Lead sponsor

Shakeela Ishrat

Other

Registry information

Official study title

The Effect of Clomiphene Citrate on Sperm Parameters in Infertile Men With Idiopathic Oligoasthenozoospermia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.