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

NCT00767338 | Terminated Phase 3 Results DMC

• 3 other identifiers: RMN-VIA5U10HD055925-025U10HD055936
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 9

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:

• 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

Keywords

Infertility; Pregnancy; Men; Palpable varicocele; Abnormal semen analysis; Intrauterine insemination; Microsurgical varicocelectomy

Outcome Measures

Primary Outcomes (1)

• Number of Live Births After Eight Cycles of Infertility Treatment.

  January 2009 to January 2012

Study Arms (4)

No surgery + IUI

ACTIVE COMPARATOR

No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.

Behavioral: Timed intercourse; Procedure: Intrauterine insemination

No Surgery + TI

ACTIVE COMPARATOR

No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.

Behavioral: Timed intercourse; Procedure: Intrauterine insemination

Surgery + IUI

ACTIVE COMPARATOR

Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.

Behavioral: Timed intercourse; Procedure: Microsurgical varicocelectomy; Procedure: Intrauterine insemination

Surgery + TI

ACTIVE COMPARATOR

Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.

Behavioral: Timed intercourse; Procedure: Microsurgical varicocelectomy; Procedure: Intrauterine insemination

Interventions

Timed intercourse BEHAVIORAL

Timed intercourse

Also known as: TI

No Surgery + TI; No surgery + IUI; Surgery + IUI; Surgery + TI

Microsurgical varicocelectomy PROCEDURE

Microsurgical varicocelectomy

Also known as: Surgery

Surgery + IUI; Surgery + TI

Intrauterine insemination PROCEDURE

Intrauterine insemination

Also known as: IUI

No Surgery + TI; No surgery + IUI; Surgery + IUI; Surgery + TI

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Penn State University: collaborator
• University of Colorado, Denver: collaborator
• University of Michigan: collaborator
• University of Pennsylvania: collaborator
• University of Texas: collaborator
• University of Vermont: collaborator
• Wayne State University: collaborator

Study Sites (9)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07601, United States

Location

Pennsylvania State University College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

• 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.

  PMID: 22130101 DERIVED

MeSH Terms

Conditions

Infertility; Multiple Endocrine Neoplasia Type 1

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Results Point of Contact

• Title: Gregory Christman, MD
• Organization: University of Michigan

growthh@umich.edu

734-764-8142

Study Officials

• Esther Eisenberg, MD, MPH

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

  STUDY DIRECTOR

• Nanette Santoro, MD

  Albert Einstein College of Medicine

  STUDY CHAIR

• Gregory M Christman, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Dana A Ohl, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Richard Legro, MD

  Pennsylvania State University College of Medicine

  STUDY DIRECTOR

• Robert Brzyski, MD, PhD

  The 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 7, 2008
• Study Start: May 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 2, 2013
• Results First Posted: May 8, 2013

Record last verified: 2013-06

Locations

US (9)