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Insulin Resistance in Idiopathic Oligospermia and Azoospermia

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ClinicalTrials.gov Identifier: NCT01509482
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
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

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): NCT01509482


Locations
Egypt
The Egyptian IVF-ET center
Cairo, Egypt, 11431
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, The Egyptian IVF-ET Center
ClinicalTrials.gov 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
Azoospermia
Oligospermia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Infertility, Male
Infertility
Genital Diseases, Male
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs