Metformin for the Treatment of Unexplained Oligozspermia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by The Egyptian IVF-ET Center
Sponsor:
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier:
NCT01529177
First received: February 4, 2012
Last updated: August 5, 2015
Last verified: August 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 The Egyptian IVF-ET Center:

Primary Outcome Measures:
  • sperm count [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ragaa Mansour, Director, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier: NCT01529177     History of Changes
Other Study ID Numbers: metformin for spermatogenesis
Study First Received: February 4, 2012
Last Updated: August 5, 2015
Health Authority: Egypt: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 30, 2015