Study Stopped
Failure to recruit participants
Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
1 other identifier
interventional
3
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 14, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 24, 2013
February 1, 2012
6 years
February 14, 2011
May 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in semen parameters
February 2017 (anticipated duration of the study)
Secondary Outcomes (1)
Change in hormone levels
February 2017 (anticipated end of the study)
Study Arms (1)
Hormone/semen measurements before and after varicocelectomy
EXPERIMENTALWe 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.
Interventions
Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes.
Eligibility Criteria
You may qualify if:
- Varicocele (grade 1-3) and surgery planned for this condition
- At least 18 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copenhagen University Hospital at Herlevlead
- Rigshospitalet, Denmarkcollaborator
Study Sites (2)
University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet
Copenhagen, 2100, Denmark
Department of Urology, Herlev Hospital
Herlev, 2730, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2011
First Posted
February 15, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
May 24, 2013
Record last verified: 2012-02