Metformin for the Treatment of Unexplained Oligozspermia

Phase 4

• Conditions: Infertility
• Interventions: Drug: Metformin / clomid / hCG; Drug: Clomiphene citrate / hCG

• Registration Number: NCT01529177
• Lead Sponsor: The Egyptian IVF-ET Center

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-04
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07
• Primary Completion: 2016-09
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 600

Inclusion Criteria

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

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Exclusion Criteria

• abnormal karyotype
• obstructive azoospermia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin / clomid / hCG	Metformin / clomid / hCG	Metformin 1000 mg orally to be given daily for one week then twice daily for 2 weeks then 3 times daily for 6 months. After 3 months from starting metformin the participant will receive 2 more medications in addition to metformin: Clomid 50 mg orally per day and 5000 IU human chorionic gonadotrophin (hCG ) IM once per week for three months.
Clomid / hCG	Clomiphene citrate / hCG	Clomid 50 mg per day will be administered orally and human chorionic gonadotrophin ( choriomon ) 5000 IU will be administered IM once per week. Both medications will be given for 6 month.

Primary Outcome Measures

Name	Time	Method
sperm count	6 months	semen analysis before the start of metformin and then every month for 6 months

Secondary Outcome Measures

Name	Time	Method
abnormal forms of spermatozoa	6 months	semen analysis before the start of metformin and then every month for 6 months

Trial Locations

Locations (1)

The Egyptian IVF-ET center; 🇪🇬 Cairo, Egypt