Metformin for the Treatment of Unexplained Hypospermatogenesis
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metformin for the Treatment of Unexplained Hypospermatogenesis|
- sperm count [ Time Frame: 6 months ] [ Designated as safety issue: No ]semen analysis before the start of metformin and then every month for 6 months
- abnormal forms of spermatozoa [ Time Frame: 6 months ] [ Designated as safety issue: No ]semen analysis before the start of metformin and then every month for 6 months
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Metformin 850 mg daily for one week then twice daily for 2 weeks then 3 times daily for 6 months.
Metformin 850 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
Other Name: Glucophage
Active Comparator: Clomid
Clomid 50 mg daily for one month then twice daily for 3 months then 3 times per dai for 3 months.
Drug: Clomiphene citrate
Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.
Other Name: Clomid
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529177
|The Egyptian IVF-ET center||Recruiting|
|Cairo, Egypt, 11431|
|Contact: Ragaa mansour 20225254955 firstname.lastname@example.org|
|Principal Investigator: Ragaa mansour, MD,PhD|
|Principal Investigator:||Ragaa mansour, MD,PhD||The Egyptian IVF-ET Center|