Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal… (NCT00767338) | Clinical Trial Compass
TerminatedPhase 3
Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis
Stopped: The DSMB recommended stopping the study because of concerns about the dismal recruitment, the drain on network resources, and the need for a study redesign.
United States3 participantsStarted 2010-05
Plain-language 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 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.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Live Births After Eight Cycles of Infertility Treatment.