NCT01529177

Metformin for the Treatment of Unexplained Oligozspermia

Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: The Egyptian IVF-ET Center · Academic / Other
• Sex: Male
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Metformin / clomid / hCG	Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
DRUG	Clomiphene citrate / hCG	Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-09-01
• Completion: 2017-02-01
• First posted: 2012-02-08
• Last updated: 2015-08-07

Locations

1 site across 1 country: Egypt