Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis
NCT ID: NCT00767338
Last Updated: 2013-07-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
3 participants
INTERVENTIONAL
2010-05-31
2011-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No surgery + IUI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Timed intercourse
Timed intercourse
Intrauterine insemination
Intrauterine insemination
No Surgery + TI
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Timed intercourse
Timed intercourse
Intrauterine insemination
Intrauterine insemination
Surgery + IUI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Timed intercourse
Timed intercourse
Microsurgical varicocelectomy
Microsurgical varicocelectomy
Intrauterine insemination
Intrauterine insemination
Surgery + TI
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Timed intercourse
Timed intercourse
Microsurgical varicocelectomy
Microsurgical varicocelectomy
Intrauterine insemination
Intrauterine insemination
Interventions
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Timed intercourse
Timed intercourse
Microsurgical varicocelectomy
Microsurgical varicocelectomy
Intrauterine insemination
Intrauterine insemination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Decreased ovarian reserve in the female partner as evidence by a day #3 FSH \> 12 mIU/ml
18 Years
50 Years
MALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Penn State University
OTHER
University of Colorado, Denver
OTHER
University of Michigan
OTHER
University of Pennsylvania
OTHER
University of Texas
OTHER
University of Vermont
OTHER
Wayne State University
OTHER
Yale University
OTHER
Responsible Party
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Heping Zhang
Principal Investigator
Principal Investigators
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Esther Eisenberg, MD, MPH
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD
Role: STUDY_CHAIR
Albert Einstein College of Medicine
Gregory M Christman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Dana A Ohl, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Richard Legro, MD
Role: STUDY_DIRECTOR
Pennsylvania State University College of Medicine
Robert Brzyski, MD, PhD
Role: STUDY_DIRECTOR
The University of Texas Health Science Center at San Antonio
Peter Casson, MD
Role: STUDY_DIRECTOR
University of Vermont
Michael Diamond, MD
Role: STUDY_DIRECTOR
Wayne State University
Heping Zhang, PhD
Role: STUDY_DIRECTOR
Yale University
Christos Coutifaris, MD
Role: STUDY_DIRECTOR
University of Pennsylvania
William D Schlaff, MD
Role: STUDY_DIRECTOR
University of Colorado Denver Health Science Center
Locations
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University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Vermont
Burlington, Vermont, United States
Countries
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References
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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.
Other Identifiers
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