Clomiphene Citrate in Infertile Men With Idiopathic Oligoasthenozoospermia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Placebo

Study Groups

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Clomiphene

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

Group Type EXPERIMENTAL

Clomiphene Citrate

Intervention Type DRUG

50 mg tab once daily

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tab once daily

Interventions

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Clomiphene Citrate

50 mg tab once daily

Intervention Type DRUG

Placebo

1 tab once daily

Intervention Type DRUG

Other Intervention Names

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Tab OVULET (Renata Pharmaceuticals Limited) Placebo provided by Renata Pharmaceuticals Limited

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No