VaricoceleNCT01296230
Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
A study testing Hormone and semen measurements before varicocelectomy in people with Varicocele and Infertility, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Varicocele, Infertility, Semen Quality
- What is being tested?
- Hormone and semen measurements before varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesDenmark
- Study dates
- Feb 2011to Feb 2017
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Varicocele (grade 1-3) and surgery planned for this condition
- At least 18 years of age
Who cannot join
- Fever within 3 months before the first semen sample
- Malformations of the uro-genital tract
- Karyotype other than 46, XY or Y micro deletions
- Endocrine disease
- Chronic disease
- Medications which reduce semen quality
- Epididymitis within 6 months before surgery
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet
Copenhagen, 2100
Department of Urology, Herlev Hospital
Herlev, 2730
About this study
The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy.
- Conditions
- Varicocele, Infertility, Semen Quality
- Being tested
- Hormone and semen measurements before varicocelectomy
- Medical subject headings
- Varicocele, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone and semen measurements before varicocelectomyProcedure or surgery
Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes.
| Study group | Role | What they receive |
|---|---|---|
| Hormone/semen measurements before and after varicocelectomy | Experimental | We will measure sex-hormone and semen quality in patients both before and after varicocelectomy. The purpose is to asses if preoperative hormone levels are predictive for who will have improved semen quality after surgery. Receives: Procedure: Hormone and semen measurements before varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in semen parameters
Measured: February 2017 (anticipated duration of the study)
Secondary outcomes (1)
Change in hormone levels
Measured: February 2017 (anticipated end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: Failure to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296230
- Sponsor's protocol ID
- H-2-2010-067
- Status last verified
- Feb 2012
- First submitted
- 14 Feb 2011
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
- ClinicalTrials.gov ID
- NCT01296230
- Acronym / sponsor ID
- H-2-2010-067
- Conditions
- Varicocele, Infertility, Semen Quality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit participants
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Feb 2011
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 15 Feb 2011 (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.
The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormone/semen measurements before and after varicocelectomy | Experimental | Procedure: Hormone and semen measurements before varicocelectomyWe will measure sex-hormone and semen quality in patients both before and after varicocelectomy. The purpose is to asses if preoperative hormone levels are predictive for who will have improved semen quality after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Varicocele (grade 1-3) and surgery planned for this condition
- At least 18 years of age
Key exclusion criteria (7 listed)
- Fever within 3 months before the first semen sample
- Malformations of the uro-genital tract
- Karyotype other than 46, XY or Y micro deletions
- Endocrine disease
- Chronic disease
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 |
|---|---|---|
| Hormone and semen measurements before varicocelectomyBefore surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes. | Procedure or surgery | Hormone/semen measurements before and after varicocelectomy |
Primary outcome
Change in semen parameters
Time frame: February 2017 (anticipated duration of the study)
1 secondary outcome
Change in hormone levels
Time frame: February 2017 (anticipated end of the study)
Results and safety
The study was stopped early (reason given: Failure to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hormone and semen measurements before varicocelectomy in people with Varicocele and Infertility, run by Copenhagen University Hospital at Herlev at 2 sites in Denmark.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 was stopped early (reason given: Failure to recruit participants). Results are not available in the source record.
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?
Change in semen parameters (time frame: February 2017 (anticipated duration of the study)). 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 24 May 2013.