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

• Sponsor: Copenhagen University Hospital at Herlev (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01296230
• Collaborator: Rigshospitalet, Denmark (Other)
• Enrollment: 3
• Locations: 2
• Arm: 1
• Duration (Months): 72
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Varicocele; Infertility; Semen Quality	Procedure: Hormone and semen measurements before varicocelectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?
• Study Start Date: Feb 1, 2011
• Anticipated Primary Completion Date: Feb 1, 2017
• Anticipated Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Change in semen parameters [February 2017 (anticipated duration of the study)]

Secondary Outcome Measures

1. Change in hormone levels [February 2017 (anticipated end of the study)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet	Copenhagen		Denmark	2100
2	Department of Urology, Herlev Hospital	Herlev		Denmark	2730

Sponsors and Collaborators

• Copenhagen University Hospital at Herlev
• Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Copenhagen University Hospital at Herlev
• ClinicalTrials.gov Identifier: NCT01296230
• Other Study ID Numbers: H-2-2010-067
• First Posted: Feb 15, 2011
• Last Update Posted: May 24, 2013
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Infertility; Varicocele; Hormones

Study Results

No Results Posted as of May 24, 2013