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Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01296230
Recruitment Status : Terminated (Failure to recruit participants)
First Posted : February 15, 2011
Last Update Posted : May 24, 2013
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev

Tracking Information
First Submitted Date  ICMJE February 14, 2011
First Posted Date  ICMJE February 15, 2011
Last Update Posted Date May 24, 2013
Study Start Date  ICMJE February 2011
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
Change in semen parameters [ Time Frame: February 2017 (anticipated duration of the study) ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
Change in semen parametres [ Time Frame: February 2017 (anticipated duration of the study) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
Change in hormone levels [ Time Frame: February 2017 (anticipated end of the study) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
Official Title  ICMJE Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Varicocele
  • Infertility
  • Semen Quality
Intervention  ICMJE Procedure: Hormone and semen measurements before varicocelectomy
Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes.
Study Arms  ICMJE Experimental: Hormone/semen measurements before and after varicocelectomy
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: Procedure: Hormone and semen measurements before varicocelectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 23, 2013)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2011)
150
Estimated Study Completion Date  ICMJE February 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01296230
Other Study ID Numbers  ICMJE H-2-2010-067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Copenhagen University Hospital at Herlev
Study Sponsor  ICMJE Copenhagen University Hospital at Herlev
Collaborators  ICMJE Rigshospitalet, Denmark
Investigators  ICMJE Not Provided
PRS Account Copenhagen University Hospital at Herlev
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP