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

Sponsors and Collaborators:	Yale University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Penn State University University of Colorado at Denver and Health Sciences Center University of Michigan University of Pennsylvania University of Texas University of Vermont Wayne State University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00767338

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	Procedure: Timed intercourse alternating with IUI Procedure: Microsurgical varicocelectomy	Phase III

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Further study details as provided by Yale University:

Primary Outcome Measures:

The primary outcome of interest is live birth rate. We will compare 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 ]

Estimated Enrollment:	232
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse	Procedure: Timed intercourse alternating with IUI No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse
2: Active Comparator Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse	Procedure: Microsurgical varicocelectomy Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse

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

Contacts

Contact: Heping Zhang, PhD	(203) 785-5185	rmn-Coordinators@masal.med.yale.edu
Contact: Meizhuo Zhang, PhD	(203) 785-6759	meizhuo.zhang@yale.edu

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, 48108
Wayne State University
Detroit, Michigan, United States, 48201
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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Penn State University

University of Colorado at Denver and Health Sciences Center

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
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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	University of Michigan ( Gregory M. Christman, M.D. and Dana A. Ohl, M.D. )
Study ID Numbers:	RMN-IUI-V
Study First Received:	October 3, 2008
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00767338
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

Infertility
Pregnancy
Men
Palpable varicocele
Abnormal semen analysis

Intrauterine insemination
Microsurgical varicocelectomy
Palpable varicocele
Abnormal semen analysis

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Varicocele
Vascular Diseases
Genital Diseases, Male

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009