NCT01509482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

January 6, 2012

Last Update Submit

November 23, 2014

Conditions

Insulin ResistanceOligospermiaAzoospermia

Keywords

insulin resistanceunexplained azoospermiaunexplained oligospermia

Outcome Measures

Primary Outcomes (1)

  • serum insulin

    one month

Secondary Outcomes (6)

  • Fasting Glucose

    one month

  • cholesterol

    one month

  • high density lipoprotein ( HDL)

    one month

  • Low density lipoprotein ( LDL )

    one month

  • testosterone

    one month

  • +1 more secondary outcomes

Study Arms (2)

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

Blood samplesOTHER

blood samples to test for primary and secondary outcome measures

Also known as: Unexplained oligospermia and azoospermia
insulin resistance

Eligibility Criteria

Age25 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • sperm count less than 10 million per milliliter
  • non-obstructive azoospermia

You may not qualify if:

  • high FSH ( \> 10 mIU/ ml )
  • high prolactin ( \> 36 mIU/ml )
  • abnormal karyotype
  • AZF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Egyptian IVF-ET center

Cairo, Egypt, 11431, Egypt

Location

MeSH Terms

Conditions

Insulin ResistanceOligospermiaAzoospermia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInfertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ragaa Mansour, MD,PhD

    The Egyptian IVF-ET Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, the Egyptian IVF-ET center

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 13, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

EG(1)