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

This study is currently recruiting participants.
Verified February 2012 by Copenhagen University Hospital at Herlev
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01296230
First received: February 14, 2011
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Varicocele
Infertility
Semen Quality
 Procedure: Hormone and semen measurements before varicocelectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Change in semen parameters [ Time Frame: February 2017 (anticipated duration of the study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in hormone levels [ Time Frame: February 2017 (anticipated end of the study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2011
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296230

Contacts
Contact: Mikkel M Fode, MD +45 38682093 mikkelfode@gmail.com
Contact: Jens R Sønksen, MD, PhD +45 21203162

Locations
Denmark
University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Ulla N Joensen, MD         ulla.nordstroem.joensen@rh.regionh.dk    
Department of Urology, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Mikkel M Fode, MD     +45 38682093     mikkelfode@gmail.com    
Principal Investigator: Mikkel M Fode, MD            
Sub-Investigator: Jens R Sønksen, MD, PhD            
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01296230     History of Changes
Other Study ID Numbers: H-2-2010-067
Study First Received: February 14, 2011
Last Updated: February 21, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Infertility
Varicocele
Genital Diseases, Male
Genital Diseases, Female
Vascular Diseases
 Cardiovascular Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013