Metformin for the Treatment of Unexplained Hypospermatogenesis | RxWiki

Metformin for the Treatment of Unexplained Hypospermatogenesis

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Infertility
Intervention	Drug: Metformin Drug: Clomiphene citrate
Phase	N/A
Sponsor	The Egyptian IVF-ET Center
Responsible Party	The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier	NCT01529177
First Received	February 4, 2012
Last Updated	November 2, 2013
Last verified	October 2013

Tracking Information[ + expand ][ + ]

First Received Date	February 4, 2012
Last Updated Date	November 2, 2013
Start Date	February 2012
Estimated Primary Completion Date	May 2015
Current Primary Outcome Measures	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
Current Secondary Outcome Measures	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

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin for the Treatment of Unexplained Hypospermatogenesis
Official Title	Metformin for the Treatment of Unexplained Hypospermatogenesis
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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Infertility
Intervention	Drug: Metformin Metformin 850 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months. Other Names: GlucophageDrug: 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 Names: Clomid
Study Arm (s)	Experimental: Metformin Metformin 850 mg daily for one week then twice daily for 2 weeks then 3 times daily for 6 months. Active Comparator: Clomid Clomid 50 mg daily for one month then twice daily for 3 months then 3 times per dai for 3 months.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	600
Estimated Completion Date	May 2015
Estimated Primary Completion Date	December 2014
Eligibility Criteria	Inclusion Criteria: - oligospermia ( < 10 million per mil-litter ) - normal FSH - high insulin Exclusion Criteria: - abnormal karyotype - obstructive azoospermia
Gender	Male
Ages	25 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Egypt

Administrative Information[ + expand ][ + ]

NCT Number	NCT01529177
Other Study ID Numbers	metformin for spermatogenesis
Has Data Monitoring Committee	Yes
Information Provided By	The Egyptian IVF-ET Center
Study Sponsor	The Egyptian IVF-ET Center
Collaborators	Not Provided
Investigators	Principal Investigator: Ragaa mansour, MD,PhD The Egyptian IVF-ET Center
Verification Date	October 2013

Locations[ + expand ][ + ]