Insulin Resistance in Idiopathic Oligospermia and Azoospermia

This study is currently recruiting participants.
Verified October 2013 by The Egyptian IVF-ET Center
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center Identifier:
First received: January 6, 2012
Last updated: November 2, 2013
Last verified: October 2013

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
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:

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: 100
Study Start Date: January 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (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 .


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


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 identifier: NCT01509482

Contact: Ragaa Mansour, MD,PhD 2012 212 2299
Contact: Ragaa Mansour, MD,PhD 202 2525 4955

The Egyptian IVF-ET center Recruiting
Cairo, Egypt, 11431
Contact: Ragaa Mansour   
Principal Investigator: Ragaa Mansour, MD,PhD         
Sponsors and Collaborators
The Egyptian IVF-ET Center
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 Identifier: NCT01509482     History of Changes
Other Study ID Numbers: insulin resistance
Study First Received: January 6, 2012
Last Updated: November 2, 2013
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
Infertility, Male
Genital Diseases, Male
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 15, 2014