Trial Outcomes & Findings for Single Embryo TrAnsfeR of Euploid Embryo (NCT NCT02268786)
NCT ID: NCT02268786
Last Updated: 2020-05-13
Results Overview
Number of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
661 participants
Primary outcome timeframe
Gestational Age of 20 Weeks
Results posted on
2020-05-13
Participant Flow
Participant milestones
| Measure |
Group A: Genetic Screening by NGS
Group A: Genetic Screening by NGS (PGT-A)
|
Group B: Morphology Only
Group B: Morphology Only (Control)
|
|---|---|---|
|
Overall Study
STARTED
|
330
|
331
|
|
Overall Study
COMPLETED
|
274
|
313
|
|
Overall Study
NOT COMPLETED
|
56
|
18
|
Reasons for withdrawal
| Measure |
Group A: Genetic Screening by NGS
Group A: Genetic Screening by NGS (PGT-A)
|
Group B: Morphology Only
Group B: Morphology Only (Control)
|
|---|---|---|
|
Overall Study
No Euploid Embryos available
|
42
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
14
|
|
Overall Study
Thaw Failure
|
6
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Single Embryo TrAnsfeR of Euploid Embryo
Baseline characteristics by cohort
| Measure |
Group A: Genetic Screening by NGS
n=330 Participants
Group A: Genetic Screening by NGS (PGT-A)
|
Group B: Morphology Only
n=331 Participants
Group B: Morphology Only (Control)
|
Total
n=661 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
|
330 Participants
n=5 Participants
|
331 Participants
n=7 Participants
|
661 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
|
33.7 years
STANDARD_DEVIATION 3.59 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 3.58 • n=7 Participants
|
33.7 years
STANDARD_DEVIATION 3.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
330 Participants
n=5 Participants
|
331 Participants
n=7 Participants
|
661 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
Canada
|
42 participants
n=5 Participants
|
32 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
244 participants
n=5 Participants
|
244 participants
n=7 Participants
|
488 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
34 participants
n=5 Participants
|
43 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Gestational Age of 20 WeeksNumber of Participants with Ongoing Pregnancy at 20 Weeks Gestation
Outcome measures
| Measure |
Group A: Genetic Screening by NGS
n=274 Participants
Group A: Genetic Screening by NGS (PGT-A)
|
Group B: Morphology Only
n=313 Participants
Group B: Morphology Only (Control)
|
|---|---|---|
|
Ongoing Pregnancy
|
137 Participants
|
143 Participants
|
Adverse Events
Group A: Genetic Screening by NGS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: Morphology Only
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
Restriction type: GT60