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Insulin Resistance in Idiopathic Oligospermia and Azoospermia

This study is currently recruiting participants.
Verified December 2012 by The Egyptian IVF-ET Center
Sponsor:
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier:
NCT01509482
First received: January 6, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

Insulin resistance in men can be the underlying major factor in reproductive abnormalities ( chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic ovarian syndrome ( PCOS ) in women.


Condition Intervention
Insulin Resistance
Oligospermia
Azoospermia
 Other: blood samples
Other: Blood samples

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Insulin Resistance : a New Diagnosis of the Pathogenesis of Idiopathic Oligozoospermia and Non Obstructive Azoospermia

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • serum insulin [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting Glucose [ Time Frame: one month ] [ Designated as safety issue: No ]
  • cholesterol [ Time Frame: one month ] [ Designated as safety issue: No ]
  • high density lipoprotein ( HDL) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Low density lipoprotein ( LDL ) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • testosterone [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: One month ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
insulin resistance
unexplained oligospermia and azoospermia
 Other: blood samples
blood samples to test for primary and secondary outcome measures
Other Name: Unexplained oligospermia and azoospermia
Fertile males
Healthy Men with proven fertility
 Other: Blood samples
IR Cholesterol HDL LDL Fasting Glucose Triglycerides
Other Name: Hypospermatogenesis

Detailed Description:

During the past decade IR has been recognized as a major contributor to the pathogenesis of chronic anovulation, hyperandrogenism and metabolic abnormalities associated with PCOS . Theoretically IR in men may result in a similar reproductive abnormalities ( chronic hypospermatogenesis ) as well as other metabolic abnormalities similar to what happens in PCOS in women .

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Infertile men

Criteria

Inclusion Criteria:

  • sperm count less than 10 million per milliliter
  • non-obstructive azoospermia

Exclusion Criteria:

  • high FSH ( > 10 mIU/ ml )
  • high prolactin ( > 36 mIU/ml )
  • abnormal karyotype
  • AZF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509482

Contacts
Contact: Ragaa Mansour, MD,PhD 2012 212 2299 ragaa.mansour@gmail.com
Contact: Ragaa Mansour, MD,PhD 202 2525 4955 ragaa.mansour@gmail.com

Locations
Egypt
The Egyptian IVF-ET center Recruiting
Cairo, Egypt, 11431
Contact: Ragaa Mansour         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, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier: NCT01509482     History of Changes
Other Study ID Numbers: insulin resistance
Study First Received: January 6, 2012
Last Updated: December 19, 2012
Health Authority: Egypt: Institutional Review Board

Keywords provided by The Egyptian IVF-ET Center:
insulin resistance
unexplained azoospermia
unexplained oligospermia

Additional relevant MeSH terms:
Insulin Resistance
Azoospermia
Oligospermia
Infertility, Male
Infertility
Genital Diseases, Male
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013