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

Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255396
• Other study ID #: CHU-209
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: September 30, 2014
• Start date: January 2009
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Azoospermia
• Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction

Intervention

Other:
• ESTRADIOL

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia		at 1 month	Yes
Primary	Issue of testicular biopsy (sperm extraction positive or negative)		at day 1	Yes
Secondary	Degrees of alteration of testis histology		at day 1	Yes
Secondary	Serum levels of estradiol and testosterone		at day 1	Yes