Back to resultsVaricocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
Primary Purpose
Varicocele, Infertility, Semen Quality
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hormone and semen measurements before varicocelectomy
Sponsored by
About this trial
This is an interventional diagnostic trial for Varicocele
Eligibility Criteria
Inclusion Criteria:
- Varicocele (grade 1-3) and surgery planned for this condition
- At least 18 years of age
Exclusion Criteria:
- 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
Sites / Locations
- University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet
- Department of Urology, Herlev Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hormone/semen measurements before and after varicocelectomy
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in semen parameters
Secondary Outcome Measures
Change in hormone levels
Full Information
NCT ID
NCT01296230
First Posted
February 14, 2011
Last Updated
May 23, 2013
Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01296230
Brief Title
Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
Official Title
Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit participants
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev
Collaborators
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele, Infertility, Semen Quality
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hormone/semen measurements before and after varicocelectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hormone and semen measurements before varicocelectomy
Intervention Description
Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes.
Primary Outcome Measure Information:
Title
Change in semen parameters
Time Frame
February 2017 (anticipated duration of the study)
Secondary Outcome Measure Information:
Title
Change in hormone levels
Time Frame
February 2017 (anticipated end of the study)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Varicocele (grade 1-3) and surgery planned for this condition
At least 18 years of age
Exclusion Criteria:
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
Facility Information:
Facility Name
University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Urology, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
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Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
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