Trial Outcomes & Findings for Impact of Sperm DNA Integrity on In Vitro Cycles (NCT NCT01232465)
NCT ID: NCT01232465
Last Updated: 2014-04-11
Results Overview
detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth
Recruitment status
COMPLETED
Target enrollment
420 participants
Primary outcome timeframe
9 months
Results posted on
2014-04-11
Participant Flow
Recruitment occured at the Center for Human Reproduction under an IRB waiver of informed consent for participation.
Participant milestones
| Measure |
IVF Cycles
those individuals undergoing conventional IVF to inseminate their retrieved eggs
|
ICSI
those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
|
|---|---|---|
|
Overall Study
STARTED
|
337
|
402
|
|
Overall Study
COMPLETED
|
337
|
402
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Sperm DNA Integrity on In Vitro Cycles
Baseline characteristics by cohort
| Measure |
IVF Cycles
n=337 Participants
those individuals undergoing conventional IVF to inseminate their retrieved eggs
|
ICSI
n=402 Participants
those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
|
Total
n=739 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
337 Participants
n=5 Participants
|
402 Participants
n=7 Participants
|
739 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
34.9 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
337 Participants
n=5 Participants
|
402 Participants
n=7 Participants
|
739 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
337 participants
n=5 Participants
|
402 participants
n=7 Participants
|
739 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsdetemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth
Outcome measures
| Measure |
IVF Cycles
n=337 Participants
those individuals undergoing conventional IVF to inseminate their retrieved eggs
|
ICSI
n=402 Participants
those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
|
|---|---|---|
|
Pregnancy
|
67 participants
|
80 participants
|
Adverse Events
IVF Cycles
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ICSI
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