Metformin for the Treatment of Unexplained Oligozspermia

August 5, 2015 updated by: Ragaa Mansour, The Egyptian IVF-ET Center

Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11431
        • Recruiting
        • The Egyptian IVF-ET Center
        • Contact:
        • Principal Investigator:
          • Ragaa mansour, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • abnormal karyotype
  • obstructive azoospermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sperm count
Time Frame: 6 months
semen analysis before the start of metformin and then every month for 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abnormal forms of spermatozoa
Time Frame: 6 months
semen analysis before the start of metformin and then every month for 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Egyptian IVF-ET Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

February 4, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • metformin for spermatogenesis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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