Insulin Resistance in Idiopathic Oligospermia and Azoospermia

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509482
• Other study ID #: insulin resistance
• Status: Completed
• Phase: N/A
• First received: January 6, 2012
• Last updated: November 23, 2014
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: November 2014
• Source: The Egyptian IVF-ET Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Azoospermia
• Insulin Resistance
• Oligospermia

Intervention

Other:
• blood samples
blood samples to test for primary and secondary outcome measures
• Blood samples
IR Cholesterol HDL LDL Fasting Glucose Triglycerides

Locations

Country	Name	City	State
Egypt	The Egyptian IVF-ET center	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
The Egyptian IVF-ET Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum insulin		one month	No
Secondary	Fasting Glucose		one month	No
Secondary	cholesterol		one month	No
Secondary	high density lipoprotein ( HDL)		one month	No
Secondary	Low density lipoprotein ( LDL )		one month	No
Secondary	testosterone		one month	No
Secondary	Triglycerides		One month	No