Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa ExtractionNCT02255396
Estradiol and Testosterone Levels in Seminal Plasma of Men With Non-obstructive Azoospermia
An observational study of Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction, run by University Hospital, Clermont-Ferrand at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction
- What is being tested?
- ESTRADIOL
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Study population: azoospermia
Who may be able to join
- 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
Who cannot join
- obstructive azoospermia
- cryptozoospermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in 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.
Read the 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.
- Being tested
- ESTRADIOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESTRADIOLOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia
Measured: at 1 month
Issue of testicular biopsy (sperm extraction positive or negative)
Measured: at day 1
Secondary outcomes (2)
Degrees of alteration of testis histology
Measured: at day 1
Serum levels of estradiol and testosterone
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa ExtractionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255396
- Sponsor's protocol ID
- CHU-209
- Status last verified
- Sep 2014
- First submitted
- 26 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia
- ClinicalTrials.gov ID
- NCT02255396
- Acronym / sponsor ID
- CHU-209
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- azoospermia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- obstructive azoospermia
- cryptozoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESTRADIOL | Other | – |
Primary outcome
Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia
Time frame: at 1 month
Issue of testicular biopsy (sperm extraction positive or negative)
Time frame: at day 1
2 secondary outcomes
Degrees of alteration of testis histology
Time frame: at day 1
Serum levels of estradiol and testosterone
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-obstructive Azoospermia With Testicular Biopsy for Spermatozoa Extraction, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of estradiol and testosterone in seminal plasma of men with non-obstuctive azoospermia (time frame: at 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014.