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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
No Surgery + IUI No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with 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.
Surgery + IUI Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Surgery + TI Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.

Participant Flow:   Overall Study
    No Surgery + IUI   No Surgery + TI   Surgery + IUI   Surgery + TI
STARTED   1   2   0   0 
COMPLETED   0   0   0   0 
NOT COMPLETED   1   2   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
No Surgery + IUI No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with 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.
Surgery + IUI Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
Surgery + TI Microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with timed intercourse.
Total Total of all reporting groups

Baseline Measures
   No Surgery + IUI   No Surgery + TI   Surgery + IUI   Surgery + TI   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   2   0   0   3 
Age 
[Units: Participants]
         
<=18 years   0   0         0 
Between 18 and 65 years   1   2         3 
>=65 years   0   0         0 
Age 
[Units: Years]
Mean (Standard Deviation)
 30  (0)   33  (1)         32  (2) 
Gender 
[Units: Participants]
         
Female   0   0         0 
Male   1   2         3 
Region of Enrollment 
[Units: Participants]
         
United States   1   2         3 


  Outcome Measures

1.  Primary:   Number of Live Births After Eight Cycles of Infertility Treatment.   [ Time Frame: January 2009 to January 2012 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: growthh@umich.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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