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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01296230
• Other study ID #: H-2-2010-067
• Status: Terminated
• Phase: N/A
• First received: February 14, 2011
• Last updated: May 23, 2013
• Start date: February 2011
• Est. completion date: February 2017

Study information

• Verified date: February 2012
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility
• Semen Quality
• Varicocele

Intervention

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.

Locations

Country	Name	City	State
Denmark	University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet	Copenhagen
Denmark	Department of Urology, Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in semen parameters		February 2017 (anticipated duration of the study)	No
Secondary	Change in hormone levels		February 2017 (anticipated end of the study)	No