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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01296230
Other study ID # H-2-2010-067
Secondary ID
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


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
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