Metformin for the Treatment of Unexplained Oligozspermia

Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529177

Enrollment

600

Registered

2012-02-08

Start date

2012-02-29

Completion date

2017-02-28

Last updated

2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Metformin, Insulin resistance, male infertility, unexplained Oligozspermia, Clomiphene citrate, Unexplained azoospermia

Brief summary

Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment with metformin.

Detailed description

Recently insulin resistance (IR) has been recognized as the underlying pathogenesis of chronic anovulation, hyperandrogenism, and metabolic abnormalities associated with PCOD in women. IR could be the underlying pathogenesis of chronic hypospermatogenesis leading to oligospermia and azoospermia associated with other metabolic abnormalities in men. Metformin has proven as an effective medication for not only IR but several other aspects of the PCOD including reproductive abnormalities. Therefore, insulin sensitizers, particularly metformin can be introduced as a pharmaceutical option for unexplained oligozoospermia and azoospermia associated with insulin resistance.

Interventions

DRUGMetformin / clomid / hCG

Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.

DRUGClomiphene citrate / hCG

Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

25 Years to 50 Years

Healthy volunteers

Inclusion criteria

* oligospermia ( \< 10 million per mil-litter ) * normal FSH * high insulin

Exclusion criteria

* abnormal karyotype * obstructive azoospermia

Design outcomes

Primary

Measure	Time frame	Description
sperm count	6 months	semen analysis before the start of metformin and then every month for 6 months

Secondary

Measure	Time frame	Description
abnormal forms of spermatozoa	6 months	semen analysis before the start of metformin and then every month for 6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026