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Insulin Resistance in Idiopathic Oligospermia and Azoospermia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ragaa Mansour, The Egyptian IVF-ET Center
ClinicalTrials.gov Identifier:
NCT01509482
First received: January 6, 2012
Last updated: November 23, 2014
Last verified: November 2014
  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: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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 ]

Enrollment: 100
Study Start Date: January 2012
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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
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: 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

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: November 23, 2014
Health Authority: Egypt: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014