Insulin Resistance in Idiopathic Oligospermia and Azoospermia

November 23, 2014 updated by: Ragaa Mansour, The Egyptian IVF-ET Center

Insulin Resistance : a New Diagnosis of the Pathogenesis of Idiopathic Oligozoospermia and Non Obstructive Azoospermia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11431
        • The Egyptian IVF-ET Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Hypospermatogenesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum insulin
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Glucose
Time Frame: one month
one month
cholesterol
Time Frame: one month
one month
high density lipoprotein ( HDL)
Time Frame: one month
one month
Low density lipoprotein ( LDL )
Time Frame: one month
one month
testosterone
Time Frame: one month
one month
Triglycerides
Time Frame: One month
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Egyptian IVF-ET Center

Investigators

  • Principal Investigator: Ragaa Mansour, MD,PhD, The Egyptian IVF-ET Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 23, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Insulin resistance

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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