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Metformin for the Treatment of Unexplained Oligozspermia

Sponsor
The Egyptian IVF-ET Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01529177
Collaborator
(none)
600
Enrollment
1
Location
2
Arms
60
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Metformin / clomid / hCG
  • Drug: Clomiphene citrate / hCG
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia
Study Start Date :
Feb 1, 2012
Anticipated Primary Completion Date :
Sep 1, 2016
Anticipated Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Metformin / clomid / hCG
Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
Other Names:
  • Glucophage / clomiphene citrate / choriomon

    		•
    Experimental: Clomid / 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.

    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.
    Other Names:
  • Clomid / choriomon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sperm count [6 months]

      semen analysis before the start of metformin and then every month for 6 months

    Secondary Outcome Measures

    1. abnormal forms of spermatozoa [6 months]

      semen analysis before the start of metformin and then every month for 6 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • oligospermia ( < 10 million per mil-litter )

    • normal FSH

    • high insulin

    Exclusion Criteria:

    • abnormal karyotype

    • obstructive azoospermia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Egyptian IVF-ET center Cairo Egypt 11431

    Sponsors and Collaborators

    • The Egyptian IVF-ET Center

    Investigators

    • Principal Investigator: Ragaa mansour, MD,PhD, The Egyptian IVF-ET Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ragaa Mansour, Director, The Egyptian IVF-ET Center
    ClinicalTrials.gov Identifier:
    NCT01529177
    Other Study ID Numbers:
    • metformin for spermatogenesis
    First Posted:
    Feb 8, 2012
    Last Update Posted:
    Aug 7, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Ragaa Mansour, Director, The Egyptian IVF-ET Center
    Metformin
    Insulin resistance
    male infertility
    unexplained Oligozspermia
    Clomiphene citrate
    Unexplained azoospermia
    Additional relevant MeSH terms:
    Infertility
    Metformin
    Citric Acid
    Sodium Citrate
    Clomiphene
    Enclomiphene
    Zuclomiphene

    Study Results

    No Results Posted as of Aug 7, 2015