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

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.

Conditions

• Pregnancy
• Infertility

Interventions

BEHAVIORAL

Timed intercourse

Timed intercourse

PROCEDURE

Microsurgical varicocelectomy

Microsurgical varicocelectomy

PROCEDURE

Intrauterine insemination

Intrauterine insemination

Sponsors & Collaborators

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

  collaborator NIH

• Penn State University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Texas

  collaborator OTHER

• University of Vermont

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• Esther Eisenberg, MD, MPH · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• Nanette Santoro, MD · Albert Einstein College of Medicine

• Gregory M Christman, MD · University of Michigan

• Dana A Ohl, MD · University of Michigan

• Richard Legro, MD · Pennsylvania State University College of Medicine

• Robert Brzyski, MD, PhD · The University of Texas Health Science Center at San Antonio

• Peter Casson, MD · University of Vermont

• Michael Diamond, MD · Wayne State University

• Heping Zhang, PhD · Yale University

• Christos Coutifaris, MD · University of Pennsylvania

• William D Schlaff, MD · University of Colorado Denver Health Science Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• United States

Study Locations