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



Status:Archived
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2010
End Date:May 2013

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


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.


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.


We found this trial at
9
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health Systems The University of Michigan is home to one of the...
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Ann Arbor, MI
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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San Antonio, TX
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Boulder, Colorado 80309
(303) 492-1411
University of Colorado, Boulder As the flagship university of the state of Colorado, CU-Boulder is...
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Boulder, CO
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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