Trial Outcomes & Findings for Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis (NCT NCT00767338)
NCT ID: NCT00767338
Last Updated: 2013-07-02
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
3 participants
Primary outcome timeframe
January 2009 to January 2012
Results posted on
2013-07-02
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Microsurgical Varicocelectomy Versus No Surgery in Men With a Palpable Varicocele and an Abnormal Semen Analysis
Baseline characteristics by cohort
| Measure |
No Surgery + IUI
n=1 Participants
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
|
No Surgery + TI
n=2 Participants
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
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
—
|
0 participants
n=21 Participants
|
|
Age Categorical
Between 18 and 65 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
—
|
—
|
3 participants
n=21 Participants
|
|
Age Categorical
>=65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
—
|
0 participants
n=21 Participants
|
|
Age Continuous
|
30 years
STANDARD_DEVIATION 0 • n=5 Participants
|
33 years
STANDARD_DEVIATION 1 • n=7 Participants
|
—
|
—
|
32 years
STANDARD_DEVIATION 2 • n=21 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
—
|
—
|
0 participants
n=21 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
—
|
—
|
3 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
—
|
—
|
3 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: January 2009 to January 2012Population: 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.
Outcome measures
| Measure |
No Surgery + IUI
n=1 Participants
No microsurgical varicocelectomy plus up to four cycles each of alternating intrauterine insemination and timed intercourse starting with intrauterine insemination.
|
No Surgery + TI
n=2 Participants
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.
|
|---|---|---|---|---|
|
Number of Live Births After Eight Cycles of Infertility Treatment.
|
0 participants
|
0 participants
|
—
|
—
|
Adverse Events
No Surgery + IUI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Surgery + TI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surgery + IUI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Surgery + TI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place