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OpenTrials
Completed

NCT Number: NCT03503877

Media, Morphokinetics, and Mosaicism

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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Key information

Conditions

Embryonic Mosaicism Embryo Culture Media Embryo Morphokinetics Genital Diseases Infertility Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EmbryoScope Plus

Device

All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data

GLOBAL MEDIA

Other

Embryos will be cultured in GLOBAL media

SAGE MEDIA

Other

Embryos will be cultured in SAGE media

Primary outcomes

  1. 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 (%)

Secondary outcomes

  1. Embryo Quality

    Time frame: 2 weeks from start of IVF treatment

    Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%).

  2. Embryonic Mosaicism

    Time frame: Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment

    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%.

  3. Embryo Morphokinetics

    Time frame: 2 weeks from start of IVF treatment

    time to first and all subsequent cell cleavages

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media

Acronym: 3M

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2018
Registry last updated
Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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