search
Back to results

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

Primary Purpose

Pregnancy, Infertility

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Timed intercourse
Microsurgical varicocelectomy
Intrauterine insemination
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

No surgery + IUI

No Surgery + TI

Surgery + IUI

Surgery + TI

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Live Births After Eight Cycles of Infertility Treatment.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2008
Last Updated
June 24, 2013
Sponsor
Yale University
Collaborators
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
search

1. Study Identification

Unique Protocol Identification Number
NCT00767338
Brief Title
Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 semen analysis in comparison to male partners who do not have microsurgical varicocelectomy. The secondary hypotheses include: To assess whether up to 4 cycles of intrauterine insemination confers any additional increase in live birth rates compared to timed intercourse; To examine spousal pregnancy rate as the secondary outcome; and 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Infertility
Keywords
Infertility, Pregnancy, Men, Palpable varicocele, Abnormal semen analysis, Intrauterine insemination, Microsurgical varicocelectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No surgery + IUI
Arm Type
Active Comparator
Arm Description
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Arm Title
No Surgery + TI
Arm Type
Active Comparator
Arm Description
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Arm Title
Surgery + IUI
Arm Type
Active Comparator
Arm Description
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Arm Title
Surgery + TI
Arm Type
Active Comparator
Arm Description
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Intervention Type
Behavioral
Intervention Name(s)
Timed intercourse
Other Intervention Name(s)
TI
Intervention Description
Timed intercourse
Intervention Type
Procedure
Intervention Name(s)
Microsurgical varicocelectomy
Other Intervention Name(s)
Surgery
Intervention Description
Microsurgical varicocelectomy
Intervention Type
Procedure
Intervention Name(s)
Intrauterine insemination
Other Intervention Name(s)
IUI
Intervention Description
Intrauterine insemination
Primary Outcome Measure Information:
Title
Number of Live Births After Eight Cycles of Infertility Treatment.
Time Frame
January 2009 to January 2012

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Eisenberg, MD, MPH
Organizational Affiliation
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nanette Santoro, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gregory M Christman, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana A Ohl, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Legro, MD
Organizational Affiliation
Pennsylvania State University College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Brzyski, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Casson, MD
Organizational Affiliation
University of Vermont
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Diamond, MD
Organizational Affiliation
Wayne State University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heping Zhang, PhD
Organizational Affiliation
Yale University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christos Coutifaris, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
William D Schlaff, MD
Organizational Affiliation
University of Colorado Denver Health Science Center
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Pennsylvania State University College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22130101
Citation
Trussell JC, Christman GM, Ohl DA, Legro RS, Krawetz SA, Snyder PJ, Patrizio P, Polotsky AJ, Diamond MP, Casson PR, Coutifaris C, Barnhart K, Brzyski RG, Schlaff WD, Meacham R, Shin D, Thomas T, Zhang M, Santoro N, Eisenberg E, Zhang H; Reproductive Medicine Network. Recruitment challenges of a multicenter randomized controlled varicocelectomy trial. Fertil Steril. 2011 Dec;96(6):1299-305. doi: 10.1016/j.fertnstert.2011.10.025.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs