Trial Outcomes & Findings for Oocyte Cryopreservation Registry (HOPE Registry) (NCT NCT00699400)
NCT ID: NCT00699400
Last Updated: 2014-01-24
Results Overview
Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.
Recruitment status
COMPLETED
Target enrollment
204 participants
Primary outcome timeframe
Birth of one or more live babies
Results posted on
2014-01-24
Participant Flow
Participant milestones
| Measure |
Slow Freeze (One Cycle)
Subjects who participated in one freezing cycle of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
|
Slow Freeze (Two Cycles)
Subjects who participated in two freezing cycles of the Registry only using the slow freeze technique (i.e. freezing that occurs at a slow rate to minimize ice formation)
|
Vitrification (One Cycle)
Subjects who participated in one freezing cycle of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
|
Vitrification (Two Cycles)
Subjects who participated in two freezing cycles of the Registry only using the vitrification technique (i.e. cryopreservation using high initial concentrations of cryoprotectant and ultra rapid cooling to solidify the cell without the formation of ice)
|
Both (Slow Freeze and Vitrification)
Participants who underwent both slow freezing and vitrification cycles (one cycle of each freezing technique).
|
Pre-freeze Discontinuations
Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
3
|
138
|
6
|
4
|
11
|
|
Overall Study
COMPLETED
|
42
|
3
|
138
|
6
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oocyte Cryopreservation Registry (HOPE Registry)
Baseline characteristics by cohort
| Measure |
Slow Freeze
n=49 Participants
Subjects that participated in one or more slow-freeze cycles
|
Vitrification
n=148 Participants
Subjects that participated in one or more vitrification cycles
|
Pre-Freeze Discontinuations
n=11 Participants
Participants who enrolled in the study but withdrew before oocyte retrieval or for whom oocyte retrieval failed (had no oocytes to freeze).
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<35 years
|
4 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Age, Customized
35-37 years
|
3 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Age, Customized
38-40 years
|
15 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Age, Customized
41-42 years
|
4 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Customized
43-44 years
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Age, Customized
> 44 years
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
208 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
BMI
|
24.6 Kg/m^2
STANDARD_DEVIATION 5.2 • n=99 Participants
|
23.4 Kg/m^2
STANDARD_DEVIATION 3.6 • n=107 Participants
|
19.7 Kg/m^2
STANDARD_DEVIATION 0 • n=206 Participants
|
23.7 Kg/m^2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
|
Donor Age
|
25.1 Years
STANDARD_DEVIATION 2.7 • n=99 Participants
|
26.0 Years
STANDARD_DEVIATION 2.8 • n=107 Participants
|
NA Years
STANDARD_DEVIATION NA • n=206 Participants
|
25.7 Years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
PRIMARY outcome
Timeframe: Birth of one or more live babiesPopulation: Live birth rate per thaw cycle(%)
Live birth rate per thawing cycle was calculated from the number of live births divided by the number of oocytes thawed less the number of embryos cryopreserved from thawed oocytes, averaged over all thawing cycles.
Outcome measures
| Measure |
Slow Freezing
n=54 Thawing Cycles
|
Vitrification
n=155 Thawing Cycles
|
All Participants
n=209 Thawing Cycles
|
|---|---|---|---|
|
Thawing Cycle Level Live Birth Rate
|
12.4 % of oocytes thawed per cycle
Interval 7.7 to 20.0
|
15.0 % of oocytes thawed per cycle
Interval 12.1 to 18.6
|
13.6 % of oocytes thawed per cycle
Interval 10.5 to 17.7
|
SECONDARY outcome
Timeframe: Birth of one or more live babiesOocyte Level Live Birth Rate was calculated from the total number of live births divided by the total number of oocytes thawed less the total number of embryos cryopreserved from thawed oocytes
Outcome measures
| Measure |
Slow Freezing
n=49 Participants
|
Vitrification
n=1133 Thawed Oocytes - Cryopreserved Embryos
|
All Participants
n=1542 Thawed Oocytes - Cryopreserved Embryos
|
|---|---|---|---|
|
Oocyte Level Live Birth Rate
|
4.2 % of all oocytes thawed
|
7.4 % of all oocytes thawed
|
6.5 % of all oocytes thawed
|
SECONDARY outcome
Timeframe: Birth of one or more live babiesOutcome measures
| Measure |
Slow Freezing
n=49 Participants
|
Vitrification
n=148 Participants
|
All Participants
n=193 Participants
|
|---|---|---|---|
|
Number of Live Babies
|
17 Number of live births
|
84 Number of live births
|
101 Number of live births
|
SECONDARY outcome
Timeframe: At cryopreservationOutcome measures
| Measure |
Slow Freezing
n=52 Freezing Cycles
|
Vitrification
n=154 Freezing Cycles
|
All Participants
n=206 Freezing Cycles
|
|---|---|---|---|
|
Number of Oocytes Frozen
|
1144 Number of Oocytes Frozen
|
3721 Number of Oocytes Frozen
|
4865 Number of Oocytes Frozen
|
SECONDARY outcome
Timeframe: At start of thawing cycleOutcome measures
| Measure |
Slow Freezing
n=54 Thawing Cycles
|
Vitrification
n=155 Thawing Cycles
|
All Participants
n=209 Thawing Cycles
|
|---|---|---|---|
|
Number of Oocytes Thawed
|
416 Number of oocytes thawed
|
1282 Number of oocytes thawed
|
1698 Number of oocytes thawed
|
SECONDARY outcome
Timeframe: At time of fertilizationNumber of oocytes fertilized divided by number of oocytes thawed per thawing cycle
Outcome measures
| Measure |
Slow Freezing
n=54 Thawing cycles
|
Vitrification
n=155 Thawing cycles
|
All Participants
n=209 Thawing cycles
|
|---|---|---|---|
|
Oocyte Survival Rate
|
73.2 Oocyte survival rate (%)
Standard Deviation 26.2
|
83.3 Oocyte survival rate (%)
Standard Deviation 20.9
|
80.6 Oocyte survival rate (%)
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: At time of ultrasound after embryo transferImplantation rate was calculated as the number of fetal sacs per transferred embryo averaged over all thawing cycles
Outcome measures
| Measure |
Slow Freezing
n=54 Thawing Cycles
|
Vitrification
n=155 Thawing Cycles
|
All Participants
n=209 Thawing Cycles
|
|---|---|---|---|
|
Implantation Rate
|
15.9 Implantation Rate (%)
Standard Deviation 24.1
|
41.7 Implantation Rate (%)
Standard Deviation 43.4
|
35.1 Implantation Rate (%)
Standard Deviation 40.9
|
SECONDARY outcome
Timeframe: At time of ultrasound after embryo transferPopulation: Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.
Number of clinical pregnancies defined as the presence of one or more fetal sacs with a heartbeat.
Outcome measures
| Measure |
Slow Freezing
n=49 Participants
|
Vitrification
n=148 Participants
|
All Participants
n=193 Participants
|
|---|---|---|---|
|
Number of Clinical Pregnancies
|
18 Number of Clinical Pregnancies
|
73 Number of Clinical Pregnancies
|
91 Number of Clinical Pregnancies
|
SECONDARY outcome
Timeframe: Anytime after embryo transferPopulation: Participants could have multiple thawing cycles that could lead to multiple embryo transfers. Only successful thaws lead to embryo transfers and only successful embryo transfers lead to clinical pregnancies.
Number of pregnancy outcomes reported as spontaneous abortions
Outcome measures
| Measure |
Slow Freezing
n=40 Embryo Transfers
|
Vitrification
n=119 Embryo Transfers
|
All Participants
n=159 Embryo Transfers
|
|---|---|---|---|
|
Number of Miscarriages
|
4 Number of Miscarriages
|
10 Number of Miscarriages
|
14 Number of Miscarriages
|
Adverse Events
Slow Freezing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vitrification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Participants
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 Institution and Principal Investigator may disclose confidential information to the extent required by law or court order, provided that they promptly provide to EMD Serono prior notice of such disclosure and provide assistance in obtaining an order protecting Confidential Information from public disclosure.
- Publication restrictions are in place
Restriction type: OTHER