Embryonic Mosaicism3MNCT03503877
Media, Morphokinetics, and Mosaicism
A study testing EmbryoScope Plus, GLOBAL MEDIA and SAGE MEDIA in people with Embryonic Mosaicism and Embryo Culture Media, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryonic Mosaicism, Embryo Culture Media, Embryo Morphokinetics
- What is being tested?
- EmbryoScope Plus, GLOBAL MEDIA and SAGE MEDIA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 28 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Female partner age >42 years of age Cleavage stage biopsy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media
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.
- Being tested
- EmbryoScope Plus, GLOBAL MEDIA, SAGE MEDIA
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbryoScope PlusDevice
All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
GLOBAL MEDIAOther
Embryos will be cultured in GLOBAL media
SAGE MEDIAOther
Embryos will be cultured in SAGE media
| Study group | Role | What they receive |
|---|---|---|
| SAGE Media | Other | SAGE single-step MEDIA Receives: Device: EmbryoScope Plus; Other: SAGE MEDIA |
| GLOBAL Media | Other | LIFE GLOBAL single-step MEDIA Receives: Device: EmbryoScope Plus; Other: GLOBAL MEDIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneuploidy Rates
number of embryos with abnormal chromosome number over total number of embryos biopsied (%)
Measured: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
Secondary outcomes (3)
Embryo Quality
Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%).
Measured: 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%.
Measured: 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
Measured: 2 weeks from start of IVF treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start14 Feb 2018
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Embryonic MosaicismStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- sibling embryo study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Rosen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503877
- Sponsor's protocol ID
- 17-22331
- Acronym
- 3M
- Status last verified
- Nov 2022
- First submitted
- 7 Feb 2018
- Last updated
- 14 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media
- ClinicalTrials.gov ID
- NCT03503877
- Acronym / sponsor ID
- 3M / 17-22331
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 14 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- sibling embryo study
| Arm | Type | Receives |
|---|---|---|
| SAGE Media | Other | Device: EmbryoScope Plus, Other: SAGE MEDIASAGE single-step MEDIA |
| GLOBAL Media | Other | Device: EmbryoScope Plus, Other: GLOBAL MEDIALIFE GLOBAL single-step MEDIA |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Female partner age >42 years of age Cleavage stage biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbryoScope PlusAll embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data | Device | GLOBAL Media, SAGE Media |
| GLOBAL MEDIAEmbryos will be cultured in GLOBAL media | Other | GLOBAL Media |
| SAGE MEDIAEmbryos will be cultured in SAGE media | Other | SAGE Media |
Primary outcome
Aneuploidy Rates
Time frame: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
number of embryos with abnormal chromosome number over total number of embryos biopsied (%)
3 secondary outcomes
Embryo Quality
Time frame: 2 weeks from start of IVF treatment
Embryonic Mosaicism
Time frame: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
Embryo Morphokinetics
Time frame: 2 weeks from start of IVF treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Embryonic Mosaicism
RecruitingObservational study
Non-Euploid Embryo Transfer (NEET) Registry
Infertility, Mosaicism
Recruiting
Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos
Aneuploidy, Mosaicism
Not yet recruitingObservational study
Prospective International Multi-center Clinical Trial of PGT-A Upgrade
Infertility Assisted Reproductive Technology
Recruiting
A Prospective Study of a Mosaic Embryo Transfer
Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Rosen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EmbryoScope Plus, GLOBAL MEDIA and SAGE MEDIA in people with Embryonic Mosaicism and Embryo Culture Media, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneuploidy Rates (time frame: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.