Insulin Resistance in Idiopathic Oligospermia and Azoospe... | NCT01509482

Studies
Insulin Resistance in Idiopathic Oligospermia and Azoospermia

NCT01509482

Sponsor

The Egyptian IVF-ET Center

Status

Completed

Last Update Posted

Nov 25, 2014Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Insulin Resistance
Oligospermia
Azoospermia

Interventions

blood samples
Blood samples

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jan 6, 2012

First Submission Date that Met QC Criteria

Jan 10, 2012

First Posted Date

Jan 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2014

Last Update Posted Date

Nov 25, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ragaa Mansour, Director, the Egyptian IVF-ET center, The Egyptian IVF-ET CenterPrincipal Investigator

Lead Sponsor

The Egyptian IVF-ET CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
insulin resistance	Experimental	unexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis.	Other: blood samples
Fertile males	Active Comparator	Healthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis	Other: Blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood samples	Other	blood samples to test for primary and secondary outcome measures	insulin resistance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum insulin		one month

Secondary Outcomes

Measure	Description	Time Frame
Fasting Glucose		one month
cholesterol		one month
high density lipoprotein ( HDL)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ragaa Mansour, MD,PhD	The Egyptian IVF-ET Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Egyptian IVF-ET center		Cairo	Egypt	11431	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance
D009845	Oligospermia
D053713	Azoospermia

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided