Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255396
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
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.

Condition or disease Intervention/treatment
Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction Other: ESTRADIOL

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
Time Perspective: Cross-Sectional
Official Title: Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2014





Primary Outcome Measures :
  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 Outcome Measures :
  1. Degrees of alteration of testis histology [ Time Frame: at day 1 ]
  2. Serum levels of estradiol and testosterone [ Time Frame: at day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
azoospermia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255396


Locations
Layout table for location information
France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02255396    
Other Study ID Numbers: CHU-209
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Azoospermia
Infertility, Male
Infertility
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs