Status:
TERMINATED
Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis
Lead Sponsor:
Yale University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
Conditions:
Pregnancy
Infertility
Eligibility:
MALE
18-50 years
Phase:
PHASE3
Brief Summary
The primary research hypothesis is that microsurgical varicocelectomy will result in an increase in live birth in infertile couples where the male partner has a palpable varicocele and an abnormal sem...
Detailed Description
Study Design This will be a randomized controlled clinical trial to examine the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele. This approach...
Eligibility Criteria
Inclusion
- 6 months of infertility (primary or secondary - randomization will be stratified to allow equal numbers of primary and secondary infertility couples in the treatment vs. observation group), male partner \> 18 years of age and \< 50 years of age
- Female partner \> 18 years of age and \<= 40 years of age - randomization will be stratified for two groups - female partner \<35 and female partner \>=35
- Evidence of a hysterosalpingogram or Saline Infusion Sonogram with one patent tube and regular ovulatory cycles as defined by the recruiting site \>25 days and \<35 days in duration in the female partner
- Evidence of a bilateral grade I or unilateral grade II-III varicocele on physical exam in the male partner
- Abnormal semen analysis as defined by WHO II criteria with a sperm count of \>5 X106 /ml or the presence of abnormal strict morphology as defined by Kruger criteria.
Exclusion
- The presence of retrograde ejaculation or uncorrectable ejaculatory dysfunction
- Decreased ovarian reserve in the female partner as evidence by a day #3 FSH \> 12 mIU/ml
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00767338
Start Date
May 1 2010
End Date
November 1 2011
Last Update
July 2 2013
Active Locations (9)
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1
University of Colorado
Aurora, Colorado, United States, 80045
2
Yale University
New Haven, Connecticut, United States, 06511
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Wayne State University
Detroit, Michigan, United States, 48201