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Metformin for the Treatment of Unexplained Oligozspermia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Ragaa Mansour, The Egyptian IVF-ET Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529177
First Posted: February 8, 2012
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
  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 Intervention Phase
Infertility Drug: Metformin / clomid / hCG Drug: Clomiphene citrate / hCG Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia

Resource links provided by NLM:


Further study details as provided by Ragaa Mansour, The Egyptian IVF-ET Center:

Primary Outcome Measures:
  • sperm count [ Time Frame: 6 months ]
    semen analysis before the start of metformin and then every month for 6 months


Secondary Outcome Measures:
  • abnormal forms of spermatozoa [ Time Frame: 6 months ]
    semen analysis before the start of metformin and then every month for 6 months


Estimated Enrollment: 600
Study Start Date: February 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Clomid / choriomon

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.
  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • abnormal karyotype
  • obstructive azoospermia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529177


Locations
Egypt
The Egyptian IVF-ET center Recruiting
Cairo, Egypt, 11431
Contact: Ragaa mansour    20225254955    ragaa.mansour@gmail.com   
Principal Investigator: Ragaa mansour, MD,PhD         
Sponsors and Collaborators
The Egyptian IVF-ET Center
Investigators
Principal Investigator: Ragaa mansour, MD,PhD The Egyptian IVF-ET Center
  More Information

Responsible Party: Ragaa Mansour, Director, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier: NCT01529177     History of Changes
Other Study ID Numbers: metformin for spermatogenesis
First Submitted: February 4, 2012
First Posted: February 8, 2012
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Ragaa Mansour, The Egyptian IVF-ET Center:
Metformin
Insulin resistance
male infertility
unexplained Oligozspermia
Clomiphene citrate
Unexplained azoospermia

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Metformin
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Chorionic Gonadotropin
Hypoglycemic Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators