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Trial record 1 of 1 for:    22130101 [PUBMED-IDS]
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Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis (VIA)

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ClinicalTrials.gov Identifier: NCT00767338
Recruitment Status : Terminated (The DSMB recommended stopping the study because of concerns about the dismal recruitment, the drain on network resources, and the need for a study redesign.)
First Posted : October 7, 2008
Results First Posted : May 8, 2013
Last Update Posted : July 2, 2013
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Information provided by (Responsible Party):
Heping Zhang, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pregnancy
Infertility
Interventions Behavioral: Timed intercourse
Procedure: Microsurgical varicocelectomy
Procedure: Intrauterine insemination
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Surgery + IUI No Surgery + TI Surgery + IUI Surgery + TI
Hide Arm/Group Description No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Period Title: Overall Study
Started 1 2 0 0
Completed 0 0 0 0
Not Completed 1 2 0 0
Arm/Group Title No Surgery + IUI No Surgery + TI Surgery + IUI Surgery + TI Total
Hide Arm/Group Description No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. Total of all reporting groups
Overall Number of Baseline Participants 1 2 0 0 3
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 0 participants 0 participants 3 participants
<=18 years 0 0 0
Between 18 and 65 years 1 2 3
>=65 years 0 0 0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 0 participants 0 participants 3 participants
30  (0) 33  (1) 32  (2)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 0 participants 0 participants 3 participants
Female 0 0 0
Male 1 2 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 0 participants 0 participants 3 participants
1 2 3
1.Primary Outcome
Title Number of Live Births After Eight Cycles of Infertility Treatment.
Hide Description [Not Specified]
Time Frame January 2009 to January 2012
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants analyzed correspond to the number of participants who completed the study. In two of the arms, the study was terminated before participants were randomized to those arms.
Arm/Group Title No Surgery + IUI No Surgery + TI Surgery + IUI Surgery + TI
Hide Arm/Group Description:
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Overall Number of Participants Analyzed 1 2 0 0
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Surgery + IUI No Surgery + TI Surgery + IUI Surgery + TI
Hide Arm/Group Description No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse. Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination. Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
All-Cause Mortality
No Surgery + IUI No Surgery + TI Surgery + IUI Surgery + TI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Surgery + IUI No Surgery + TI Surgery + IUI Surgery + TI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%)   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Surgery + IUI No Surgery + TI Surgery + IUI Surgery + TI
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%)   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gregory Christman, MD
Organization: University of Michigan
Phone: 734-764-8142
Responsible Party: Heping Zhang, Yale University
ClinicalTrials.gov Identifier: NCT00767338     History of Changes
Other Study ID Numbers: RMN-VIA
5U10HD055925-02 ( U.S. NIH Grant/Contract )
5U10HD055936 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2008
First Posted: October 7, 2008
Results First Submitted: December 12, 2012
Results First Posted: May 8, 2013
Last Update Posted: July 2, 2013