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CompletedNCT01509482Updated Nov 25, 2014

Insulin Resistance in Idiopathic Oligospermia and Azoospermia

An interventional study of blood samples and Blood samples in Insulin Resistance, Oligospermia and Azoospermia, sponsored by The Egyptian IVF-ET Center. Completed at 1 site in Egypt. Open to male participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-25.

Sponsored by The Egyptian IVF-ET Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
25 Years to 55 Years
Sex
Male
01

Study 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.

Read the 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 .

02

Conditions studied

  • Insulin Resistance
  • Oligospermia
  • Azoospermia

Keywords

  • insulin resistance
  • unexplained azoospermia
  • unexplained oligospermia
03

In context

Azoospermia

69 studies on the registry are indexed under Azoospermia; 19 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 38 interventional studies indexed under Azoospermia.

Browse Azoospermia studies →

Lead sponsor

The Egyptian IVF-ET Center is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • high FSH ( > 10 mIU/ ml )
  • high prolactin ( > 36 mIU/ml )
  • abnormal karyotype
  • AZF
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    insulin resistance

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

    Other: blood samples

  • Active comparator
    Fertile males

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

    Other: Blood samples

Interventions

  • Otherblood samples

    blood samples to test for primary and secondary outcome measures

    Also known as: Unexplained oligospermia and azoospermia

  • OtherBlood samples

    IR Cholesterol HDL LDL Fasting Glucose Triglycerides

    Also known as: Hypospermatogenesis

06

What researchers measure

Primary outcomes

  1. serum insulin

    Time frame: one month

Secondary outcomes

  1. Fasting Glucose

    Time frame: one month

  2. cholesterol

    Time frame: one month

  3. high density lipoprotein ( HDL)

    Time frame: one month

  4. Low density lipoprotein ( LDL )

    Time frame: one month

  5. testosterone

    Time frame: one month

  6. Triglycerides

    Time frame: One month

07

Study locations

1 site
  • The Egyptian IVF-ET center
    Cairo, 11431, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01509482
Lead sponsor
The Egyptian IVF-ET Center
Responsible party
Ragaa Mansour (Director, the Egyptian IVF-ET center, The Egyptian IVF-ET Center) — Principal investigator
First posted
Jan 13, 2012
Start date
Jan 2012
Primary completion
Jan 2014
Completion
Apr 2014
Last update
Nov 25, 2014

Study contacts

Ragaa Mansour, MD,PhD
principal investigator · The Egyptian IVF-ET Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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