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Completed

NCT Number: NCT01509482

Insulin Resistance in Idiopathic Oligospermia and Azoospermia

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.

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Key information

Conditions

Insulin Resistance Azoospermia Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Hyperinsulinism Infertility Infertility, Male Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Oligospermia Urogenital Diseases

Age range

25 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Egyptian IVF-ET center

Cairo, Egypt, 11431

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

blood samples to test for primary and secondary outcome measures

Other names: Unexplained oligospermia and azoospermia

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

Sponsors and collaborators

Lead sponsor

The Egyptian IVF-ET Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2012
Registry last updated
Nov 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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