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

Infertility Clinical Trial

— VIA  

Official title:

A Prospective, Randomized, Study of Microsurgical Varicocelectomy Versus Observation in the Treatment of Male Partners With a Palpable Varicocele and an Abnormal Semen Analysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767338
• Other study ID #: RMN-VIA
• Secondary ID: 5U10HD055925-025
• Status: Terminated
• Phase: Phase 3
• First received: October 3, 2008
• Last updated: June 24, 2013
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: June 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 will allow us to compare (i) the effect of microsurgical varicocelectomy on live birth rates after up to four cycles of alternating intrauterine insemination and four cycles of timed intercourse over 8 months and (ii) the relative effectiveness of intrauterine insemination versus timed intercourse on live birth rates. Secondary analyses will explore the effect of the surgical intervention on pregnancy rates, semen analysis parameters, serological hormonal measures in the male subjects, and quality of life measures in both the male and female partners.

Treatment

Two hundred and thirty-two couples will be randomized to the two intervention groups (microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse or no microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse).

Timing

We anticipate that it will take 3 years to complete the study. Enrollment will begin in year 1 of the study. 34 couples will need to be recruited per site over the duration of the study to reach the enrollment goal of 232 couples. Participants will be enrolled in the study for one year, with the male partner undergoing periodic study assessments at two month intervals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Pregnancy
• Varicocele

Intervention

Behavioral:
• Timed intercourse
Timed intercourse

Procedure:
• Microsurgical varicocelectomy
Microsurgical varicocelectomy
• Intrauterine insemination
Intrauterine insemination

Locations

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

Sponsors (9)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Live Births After Eight Cycles of Infertility Treatment.		January 2009 to January 2012	No