Trial Outcomes & Findings for Media, Morphokinetics, and Mosaicism (NCT NCT03503877)
NCT ID: NCT03503877
Last Updated: 2022-12-14
Results Overview
number of embryos with abnormal chromosome number over total number of embryos biopsied (%)
COMPLETED
NA
200 participants
Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
2022-12-14
Participant Flow
Enrollment occurred between February 2018 and November 2019. All individuals planning in vitro fertilization with intent for blastocyst culture and PGT-A at UCSF Center for Reproductive Health were offered enrollment prior to their treatment cycle
Of 200 subjects enrolled, 1 subject was pregnant before her planned IVF cycle, 8 subjects were canceled prior to retrieval, 3 chose to withdraw from the study, 11 were found to be ineligible and 1 was withdrawn by study personnel due to the conversion to an oocyte cryopreservation cycle. As a result, 176 subjects underwent egg retrieval. Of these, 49 were removed from analysis for not having paired embryos and 127 had paired embryo sets in each culture arm and were able to complete the study.
Unit of analysis: Paired embryo sets
Participant milestones
| Measure |
SAGE Media
SAGE single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
SAGE MEDIA: Embryos will be cultured in SAGE media
|
GLOBAL Media
LIFE GLOBAL single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
GLOBAL MEDIA: Embryos will be cultured in GLOBAL media
|
|---|---|---|
|
Overall Study
STARTED
|
127 127
|
127 127
|
|
Overall Study
COMPLETED
|
127 127
|
127 127
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Media, Morphokinetics, and Mosaicism
Baseline characteristics by cohort
| Measure |
All Study Participants
n=127 Paired embryo sets
All study participants had paired embryo sets in each culture arm (SAGE Media or GLOBAL Media).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=127 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
127 Participants
n=127 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=127 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=127 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=127 Participants
|
PRIMARY outcome
Timeframe: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatmentnumber of embryos with abnormal chromosome number over total number of embryos biopsied (%)
Outcome measures
| Measure |
SAGE Media
n=127 Paired embryo sets
SAGE single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
SAGE MEDIA: Embryos will be cultured in SAGE media
|
GLOBAL Media
n=127 Paired embryo sets
LIFE GLOBAL single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
GLOBAL MEDIA: Embryos will be cultured in GLOBAL media
|
|---|---|---|
|
Aneuploidy Rates
|
56.1 percentage of embryos
Standard Deviation 34.4
|
62.3 percentage of embryos
Standard Deviation 34
|
SECONDARY outcome
Timeframe: 2 weeks from start of IVF treatmentFraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%).
Outcome measures
| Measure |
SAGE Media
n=127 Paired embryo sets
SAGE single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
SAGE MEDIA: Embryos will be cultured in SAGE media
|
GLOBAL Media
n=127 Paired embryo sets
LIFE GLOBAL single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
GLOBAL MEDIA: Embryos will be cultured in GLOBAL media
|
|---|---|---|
|
Embryo Quality
|
45.7 percentage of embryos
Standard Deviation 31.1
|
45.6 percentage of embryos
Standard Deviation 30.8
|
SECONDARY outcome
Timeframe: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatmentFraction of embryos given mosaic diagnosis. Embryonic mosaicism is defined as having partial aneuploidy (20-80% aneuploid). Low-level mosaicism is defined as 20-40% whereas high-level mosaicism is defined as 40-80%.
Outcome measures
| Measure |
SAGE Media
n=127 Participants
SAGE single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
SAGE MEDIA: Embryos will be cultured in SAGE media
|
GLOBAL Media
n=127 Participants
LIFE GLOBAL single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
GLOBAL MEDIA: Embryos will be cultured in GLOBAL media
|
|---|---|---|
|
Embryonic Mosaicism
High Mosaic expression rate (40-80%)
|
15.9 percentage of embryos
Standard Deviation 25.7
|
18.9 percentage of embryos
Standard Deviation 30.5
|
|
Embryonic Mosaicism
Low Mosaic expression rate (20-40%)
|
1.0 percentage of embryos
Standard Deviation 5.9
|
2.2 percentage of embryos
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 2 weeks from start of IVF treatmenttime to first and all subsequent cell cleavages
Outcome measures
| Measure |
SAGE Media
n=127 Paired embryo sets
SAGE single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
SAGE MEDIA: Embryos will be cultured in SAGE media
|
GLOBAL Media
n=127 Paired embryo sets
LIFE GLOBAL single-step MEDIA
EmbryoScope Plus: All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
GLOBAL MEDIA: Embryos will be cultured in GLOBAL media
|
|---|---|---|
|
Embryo Morphokinetics
2 cell formation
|
28.1 Hours
Standard Deviation 3.9
|
28.4 Hours
Standard Deviation 4.3
|
|
Embryo Morphokinetics
3 cell formation
|
38.5 Hours
Standard Deviation 6.6
|
39.5 Hours
Standard Deviation 6.6
|
|
Embryo Morphokinetics
4 cell formation
|
40.6 Hours
Standard Deviation 5.3
|
41.2 Hours
Standard Deviation 6
|
|
Embryo Morphokinetics
5 cell formation
|
50.6 Hours
Standard Deviation 6.5
|
52.3 Hours
Standard Deviation 8.2
|
|
Embryo Morphokinetics
6 cell formation
|
54.5 Hours
Standard Deviation 8.3
|
55.4 Hours
Standard Deviation 7.6
|
|
Embryo Morphokinetics
7 cell formation
|
58.2 Hours
Standard Deviation 8.1
|
58.8 Hours
Standard Deviation 8.6
|
|
Embryo Morphokinetics
8 cell formation
|
61.9 Hours
Standard Deviation 8.7
|
62.5 Hours
Standard Deviation 9
|
|
Embryo Morphokinetics
Morula Formation
|
92 Hours
Standard Deviation 8.9
|
93.4 Hours
Standard Deviation 8.6
|
|
Embryo Morphokinetics
Start of Blastulation
|
102.6 Hours
Standard Deviation 8.1
|
104 Hours
Standard Deviation 8.2
|
|
Embryo Morphokinetics
Blastocyst Formation
|
110.6 Hours
Standard Deviation 7.8
|
111.8 Hours
Standard Deviation 7.6
|
|
Embryo Morphokinetics
Expanded Blastocyst Formation
|
120.3 Hours
Standard Deviation 8.1
|
122.5 Hours
Standard Deviation 8.2
|
Adverse Events
SAGE Media
GLOBAL Media
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