Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis (VIA)
Pregnancy, Infertility
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Infertility, Pregnancy, Men, Palpable varicocele, Abnormal semen analysis, Intrauterine insemination, Microsurgical varicocelectomy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Colorado
- Yale University
- University of Michigan
- Wayne State University
- University of Medicine and Dentistry of New Jersey
- Pennsylvania State University College of Medicine
- University of Pennsylvania
- University of Texas Health Science Center at San Antonio
- University of Vermont
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
No surgery + IUI
No Surgery + TI
Surgery + IUI
Surgery + TI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.