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Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia

S

Shakeela Ishrat

Status and phase

Completed
Phase 3

Conditions

Infertility, Male

Treatments

Drug: Clomiphene Citrate
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Male

Ages

25 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups, including a placebo group

Clomiphene
Experimental group
Description:
Participants will receive Tab Clomiphene citrate 50 mg orally once daily or 12 weeks
Treatment:
Drug: Clomiphene Citrate
Placebo
Placebo Comparator group
Description:
Participants will receive Clomiphene citrate placebo tablet matching Clomiphene citrate orally once daily for 12 weeks
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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