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Completed

NCT Number: NCT02255396

Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia

Estradiol and Testosterone are two important hormones for the regulation of an effective spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in seminal plasma of men with non-obstructive azoospermia may be a predictive test before surgical testicular biopsy to determine the chance of a positive sperm extraction to use for ICSI.

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Key information

Conditions

Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction

Age range

18 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

The aim of this study is to compare the levels of esttradiol and testosterone in seminal plasma of men with non-obstructive azoospermia. Indeed, for these patients, none biological test allows to predict a positive sperm extraction before the surgical testis biopsy is performed. Since the involvement of estradiol and testosterone in the regulation of spermatogenesis, the measurement of these hormones in seminal plasma may be a predictive tool for these men before testis biopsy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Azoospermia confirmed by two semen analysis (at minimum 74 days between the both analysis)
  • Volume of seminal plasma >0.6ml
  • Testicular biopsy one month after the last semen analysis
  • Informed consent signed by the patient

Exclusion criteria

  • obstructive azoospermia
  • cryptozoospermia

Treatment and study plan

Estradiol

Other

Primary outcomes

  1. Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia

    Time frame: at 1 month

  2. Issue of testicular biopsy (sperm extraction positive or negative)

    Time frame: at day 1

Secondary outcomes

  1. Degrees of alteration of testis histology

    Time frame: at day 1

  2. Serum levels of estradiol and testosterone

    Time frame: at day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Oct 2, 2014
Registry last updated
Oct 2, 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.