Insulin Resistance in Idiopathic Oligospermia and Azoospermia

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. Identifier: NCT01509482
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : November 25, 2014
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center

Brief Summary:
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 or disease Intervention/treatment
Insulin Resistance Oligospermia Azoospermia Other: blood samples Other: Blood samples

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 .

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Insulin Resistance : a New Diagnosis of the Pathogenesis of Idiopathic Oligozoospermia and Non Obstructive Azoospermia
Study Start Date : January 2012
Primary Completion Date : January 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: insulin resistance
unexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis.
Other: blood samples
blood samples to test for primary and secondary outcome measures
Other Name: Unexplained oligospermia and azoospermia
Active Comparator: Fertile males
Healthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis
Other: Blood samples
IR Cholesterol HDL LDL Fasting Glucose Triglycerides
Other Name: Hypospermatogenesis

Primary Outcome Measures :
  1. serum insulin [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Fasting Glucose [ Time Frame: one month ]
  2. cholesterol [ Time Frame: one month ]
  3. high density lipoprotein ( HDL) [ Time Frame: one month ]
  4. Low density lipoprotein ( LDL ) [ Time Frame: one month ]
  5. testosterone [ Time Frame: one month ]
  6. Triglycerides [ Time Frame: One month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01509482

The Egyptian IVF-ET center
Cairo, Egypt, 11431
Sponsors and Collaborators
The Egyptian IVF-ET Center
Principal Investigator: Ragaa Mansour, MD,PhD The Egyptian IVF-ET Center

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
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Infertility, Male
Genital Diseases, Male
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs