Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis

Stopped early · Phase 3

Conditions studied: Pregnancy, Infertility

In brief

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 semen analysis in comparison to male partners who do not have microsurgical varicocelectomy. The secondary hypotheses include: 1. To assess whether up to 4 cycles of intrauterine insemination confers any additional increase in live birth rates compared to timed intercourse; 2. To examine spousal pregnancy rate as the secondary outcome; and 3. To study the effect of varicocelectomy in men with infertility, an abnormal semen analysis, and a palpable varicocele on * Testicular semen analysis parameters; * Serological measures of FSH, LH, total and free testosterone and * Measures of quality of life and sexual function in both partners.

Key facts

Study ID

NCT00767338

Run by

Yale University

People needed

3

Starts

2010-05-01

Expected to finish

2011-11-01

Last updated by the study team

2013-07-02

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Colorado — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• University of Medicine and Dentistry of New Jersey — Newark, New Jersey, United States
• Pennsylvania State University College of Medicine — Hershey, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.