Trial Outcomes & Findings for IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing (NCT NCT02026193)
NCT ID: NCT02026193
Last Updated: 2015-06-08
Results Overview
Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
1 month after embryo transfer
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
Oocyte Vitrification
All retrieved mature oocytes will be vitrified.
oocyte vitrification
|
Embryo Freezing
All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
|
Overall Study
COMPLETED
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing
Baseline characteristics by cohort
| Measure |
Oocyte Vitrification
n=3 Participants
All retrieved mature oocytes will be vitrified.
oocyte vitrification
|
Embryo Freezing
n=8 Participants
All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 5.5 • n=39 Participants
|
25 years
STANDARD_DEVIATION 2.6 • n=41 Participants
|
28.3 years
STANDARD_DEVIATION 5.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=39 Participants
|
8 participants
n=41 Participants
|
11 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 1 month after embryo transferFetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer
Outcome measures
| Measure |
Oocyte Vitrification
n=3 Participants
All retrieved mature oocytes will be vitrified.
oocyte vitrification
|
Embryo Freezing
n=8 Participants
All retrieved oocytes will be fertilized, and resulting embryos will be frozen.
embryo freezing
|
|---|---|---|
|
Fetal Heart Activity 1 Month Post Embryo Transfer
|
0 participants with fetal heart activity
|
4 participants with fetal heart activity
|
Adverse Events
Oocyte Vitrification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Embryo Freezing
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
Dr Shahar Kol , Director IVF Unit
Rambam health Care campus
Phone: 97247773232
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place