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TerminatedNCT01296230Updated May 24, 2013

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

An interventional study of Hormone and semen measurements before varicocelectomy in Varicocele, Infertility and Semen Quality, sponsored by Copenhagen University Hospital at Herlev. Terminated at 2 sites in Denmark. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-24.

Sponsored by Copenhagen University Hospital at Herlev · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Failure to recruit participants
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Varicocele
  • Infertility
  • Semen Quality
03

In context

Varicocele

53 studies on the registry are indexed under Varicocele; 15 are open to participants now.

This study's enrollment of 3 is below the median of 72 across 36 interventional studies indexed under Varicocele.

Browse Varicocele studies →

Lead sponsor

Copenhagen University Hospital at Herlev is the lead sponsor of 77 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Varicocele (grade 1-3) and surgery planned for this condition
  • At least 18 years of age

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureHormone 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.

06

What researchers measure

Primary outcomes

  1. Change in semen parameters

    Time frame: February 2017 (anticipated duration of the study)

Secondary outcomes

  1. Change in hormone levels

    Time frame: February 2017 (anticipated end of the study)

07

Study locations

2 sites
  • University Department of Growth and Reproduction GR, Section 5064, Rigshospitalet
    Copenhagen, 2100, Denmark
  • Department of Urology, Herlev Hospital
    Herlev, 2730, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01296230
Lead sponsor
Copenhagen University Hospital at Herlev
Responsible party
Sponsor
First posted
Feb 15, 2011
Start date
Feb 2011
Primary completion
Feb 2017 (estimated)
Completion
Feb 2017 (estimated)
Last update
May 24, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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