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Media, Morphokinetics, and Mosaicism (3M)

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Infertility
Embryo Culture Media
Embryonic Mosaicism
Embryo Morphokinetics

Treatments

Other: GLOBAL MEDIA
Device: EmbryoScope Plus
Other: SAGE MEDIA

Study type

Interventional

Funder types

Other

Identifiers

NCT03503877
17-22331

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

Female

Ages

18 to 42 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups

SAGE Media
Other group
Description:
SAGE single-step MEDIA
Treatment:
Other: SAGE MEDIA
Device: EmbryoScope Plus
GLOBAL Media
Other group
Description:
LIFE GLOBAL single-step MEDIA
Treatment:
Other: GLOBAL MEDIA
Device: EmbryoScope Plus

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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