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Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAGE Media | Other | SAGE single-step MEDIA |
|
| GLOBAL Media | Other | LIFE GLOBAL single-step MEDIA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmbryoScope Plus | Device | All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aneuploidy Rates | number of embryos with abnormal chromosome number over total number of embryos biopsied (%) | Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Embryo Quality | Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%). | 2 weeks from start of IVF treatment |
| Embryonic Mosaicism | Fraction 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%. |
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Inclusion Criteria:
All subjects planning blastocyst culture for preimplantation genetic screening (PGS) will be offered enrollment.
Antral Follicle Count (AFC) >8 Male and female partner > 18 years of age
Exclusion Criteria:
Female partner age >42 years of age Cleavage stage biopsy
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Rosen, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94158 | United States |
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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.
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
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All study participants had paired embryo sets in each culture arm (SAGE Media or GLOBAL Media). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aneuploidy Rates | number of embryos with abnormal chromosome number over total number of embryos biopsied (%) | Posted | Mean | Standard Deviation | percentage of embryos | Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment | Paired embryo sets | Paired embryo sets |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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A limitation of our study is the absence of long-term outcome data including pregnancy outcomes and offspring health data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Rosen | University of California, San Francisco | 415-353-7475 | Mitchell.Rosen@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2017 | May 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D020669 | Fetoscopes |
| ID | Term |
|---|---|
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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sibling embryo study
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| GLOBAL MEDIA | Other | Embryos will be cultured in GLOBAL media |
|
| SAGE MEDIA | Other | Embryos will be cultured in SAGE media |
|
| Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment |
| Embryo Morphokinetics | time to first and all subsequent cell cleavages | 2 weeks from start of IVF treatment |
| Paired embryo sets |
|
| Participants |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| Secondary | Embryo Quality | Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%). | Posted | Mean | Standard Deviation | percentage of embryos | 2 weeks from start of IVF treatment | Paired embryo sets | Paired embryo sets |
|
|
|
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| Secondary | Embryonic Mosaicism | Fraction 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%. | Posted | Mean | Standard Deviation | percentage of embryos | Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment | Paired embryo sets | Paired embryo sets |
|
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|
|
| Secondary | Embryo Morphokinetics | time to first and all subsequent cell cleavages | Posted | Mean | Standard Deviation | Hours | 2 weeks from start of IVF treatment | Paired embryo sets | Paired embryo sets |
|
|
|
|
| 0 |
| 127 |
| 0 |
| 127 |
| 0 |
| 127 |
| EG001 | 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 | 0 | 127 | 0 | 127 | 0 | 127 |
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Low mosaicism |
| Superiority |
| 4 cell formation |
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| 5 cell formation |
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| 6 cell formation |
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| 7 cell formation |
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| 8 cell formation |
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| Morula Formation |
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| Start of Blastulation |
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| Blastocyst Formation |
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| Expanded Blastocyst Formation |
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