Metformin for the Treatment of Unexplained Oligozspermia

Infertility Clinical Trial

Official title:

Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01529177
• Other study ID #: metformin for spermatogenesis
• Status: Recruiting
• Phase: Phase 4
• First received: February 4, 2012
• Last updated: August 5, 2015
• Start date: February 2012
• Est. completion date: February 2017

Study information

• Verified date: August 2015
• Source: The Egyptian IVF-ET Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• oligospermia ( < 10 million per mil-litter )

• normal FSH

• high insulin

Exclusion Criteria:

• abnormal karyotype

• obstructive azoospermia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Metformin / clomid / hCG
Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
• 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.

Locations

Country	Name	City	State
Egypt	The Egyptian IVF-ET center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
The Egyptian IVF-ET Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sperm count	semen analysis before the start of metformin and then every month for 6 months	6 months	No
Secondary	abnormal forms of spermatozoa	semen analysis before the start of metformin and then every month for 6 months	6 months	No