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Insulin Resistance in Idiopathic Oligospermia and Azoospermia

Primary Purpose

Insulin Resistance, Oligospermia, Azoospermia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
blood samples
Blood samples
Sponsored by
The Egyptian IVF-ET Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Insulin Resistance focused on measuring insulin resistance, unexplained azoospermia, unexplained oligospermia

Eligibility Criteria

25 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • The Egyptian IVF-ET center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

insulin resistance

Fertile males

Arm Description

unexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis.

Healthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis

Outcomes

Primary Outcome Measures

serum insulin

Secondary Outcome Measures

Fasting Glucose
cholesterol
high density lipoprotein ( HDL)
Low density lipoprotein ( LDL )
testosterone
Triglycerides

Full Information

First Posted
January 6, 2012
Last Updated
November 23, 2014
Sponsor
The Egyptian IVF-ET Center
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1. Study Identification

Unique Protocol Identification Number
NCT01509482
Brief Title
Insulin Resistance in Idiopathic Oligospermia and Azoospermia
Official Title
Insulin Resistance : a New Diagnosis of the Pathogenesis of Idiopathic Oligozoospermia and Non Obstructive Azoospermia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Egyptian IVF-ET Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Oligospermia, Azoospermia
Keywords
insulin resistance, unexplained azoospermia, unexplained oligospermia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin resistance
Arm Type
Experimental
Arm Description
unexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis.
Arm Title
Fertile males
Arm Type
Active Comparator
Arm Description
Healthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis
Intervention Type
Other
Intervention Name(s)
blood samples
Other Intervention Name(s)
Unexplained oligospermia and azoospermia
Intervention Description
blood samples to test for primary and secondary outcome measures
Intervention Type
Other
Intervention Name(s)
Blood samples
Other Intervention Name(s)
Hypospermatogenesis
Intervention Description
IR Cholesterol HDL LDL Fasting Glucose Triglycerides
Primary Outcome Measure Information:
Title
serum insulin
Time Frame
one month
Secondary Outcome Measure Information:
Title
Fasting Glucose
Time Frame
one month
Title
cholesterol
Time Frame
one month
Title
high density lipoprotein ( HDL)
Time Frame
one month
Title
Low density lipoprotein ( LDL )
Time Frame
one month
Title
testosterone
Time Frame
one month
Title
Triglycerides
Time Frame
One month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragaa Mansour, MD,PhD
Organizational Affiliation
The Egyptian IVF-ET Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Egyptian IVF-ET center
City
Cairo
ZIP/Postal Code
11431
Country
Egypt

12. IPD Sharing Statement

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Insulin Resistance in Idiopathic Oligospermia and Azoospermia

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