Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis (VIA)
This study has been terminated.
(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.)
Sponsor:
Yale University
Collaborators:
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00767338
First received: October 3, 2008
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy Infertility |
Behavioral: Timed intercourse Procedure: Microsurgical varicocelectomy Procedure: Intrauterine insemination |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Live Birth Rates for the Intervention and Control Groups After Eight Cycles of Infertility Treatment. [ Time Frame: January 2009 to January 2012 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Conversion to Pregnancy [ Time Frame: January 2009 to January 2012 ] [ Designated as safety issue: No ]
- Testicular Volume, Total and Free Testosterone, and Sperm Concentration, Motility or Morphology After the Intervention [ Time Frame: January 2009 to January 2012 ] [ Designated as safety issue: No ]
- Quality of Life and Sexual Function Between the Intervention and Control Groups for Both the Male and Female Partner [ Time Frame: January 2009 to January 2012 ] [ Designated as safety issue: No ]
- The Relative Effectiveness of Intrauterine Insemination vs. Timed Intercourse in Achieving a Pregnancy [ Time Frame: January 2009 to January 2012 ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | May 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: No surgery + IUI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
|
Behavioral: Timed intercourse
Timed intercourse
Other Name: TI
Procedure: Intrauterine insemination
Intrauterine insemination
Other Name: IUI
|
|
Active Comparator: No Surgery + TI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
|
Behavioral: Timed intercourse
Timed intercourse
Other Name: TI
Procedure: Intrauterine insemination
Intrauterine insemination
Other Name: IUI
|
|
Active Comparator: Surgery + IUI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
|
Behavioral: Timed intercourse
Timed intercourse
Other Name: TI
Procedure: Microsurgical varicocelectomy
Microsurgical varicocelectomy
Other Name: Surgery
Procedure: Intrauterine insemination
Intrauterine insemination
Other Name: IUI
|
|
Active Comparator: Surgery + TI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
|
Behavioral: Timed intercourse
Timed intercourse
Other Name: TI
Procedure: Microsurgical varicocelectomy
Microsurgical varicocelectomy
Other Name: Surgery
Procedure: Intrauterine insemination
Intrauterine insemination
Other Name: IUI
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767338
Locations
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07601 | |
| United States, Pennsylvania | |
| Pennsylvania State University College of Medicine | |
| Hershey, Pennsylvania, United States, 17033 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78207 | |
| United States, Vermont | |
| University of Vermont | |
| Burlington, Vermont, United States, 05405 | |
Sponsors and Collaborators
Yale University
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Investigators
| Study Director: | Esther Eisenberg, MD, MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Study Chair: | Nanette Santoro, MD | Albert Einstein College of Medicine of Yeshiva University |
| Principal Investigator: | Gregory M Christman, MD | University of Michigan |
| Principal Investigator: | Dana A Ohl, MD | University of Michigan |
| Study Director: | Richard Legro, MD | Pennsylvania State University College of Medicine |
| Study Director: | Robert Brzyski, MD, PhD | University of Texas Health Science Center at San Antonio |
| Study Director: | Peter Casson, MD | University of Vermont |
| Study Director: | Michael Diamond, MD | Wayne State University |
| Study Director: | Heping Zhang, PhD | Yale University |
| Study Director: | Christos Coutifaris, MD | University of Pennsylvania |
| Study Director: | William D Schlaff, MD | University of Colorado Denver Health Science Center |
More Information
Additional Information:
No publications provided by Yale University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00767338 History of Changes |
| Other Study ID Numbers: | RMN-VIA, 5U10HD055925-02, 5U10HD055936 |
| Study First Received: | October 3, 2008 |
| Results First Received: | December 12, 2012 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
Infertility Pregnancy Men Palpable varicocele |
Abnormal semen analysis Intrauterine insemination Microsurgical varicocelectomy |
Additional relevant MeSH terms:
|
Infertility Varicocele Genital Diseases, Male |
Genital Diseases, Female Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013