Media, Morphokinetics, and Mosaicism

Not Applicable

Completed

• Conditions: Embryonic Mosaicism; Embryo Morphokinetics; Embryo Culture Media; Infertility
• Interventions: Device: EmbryoScope Plus; Other: SAGE MEDIA; Other: GLOBAL MEDIA

• Registration Number: NCT03503877
• Lead Sponsor: University of California, San Francisco

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-07
• Study Start: 2018-02-14
• Study First Submitted QC: 2018-04-11
• Study First Posted: 2018-04-20
• Primary Completion: 2019-11-28
• Study Completion: 2019-11-28
• Disposition First Submitted: 2021-01-15
• Results First Submitted: 2022-05-26
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-17
• Disposition First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Results First Posted: 2022-12-14
• Disposition First Posted: 2022-12-14
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

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Exclusion Criteria

Female partner age >42 years of age Cleavage stage biopsy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLOBAL Media	EmbryoScope Plus	LIFE GLOBAL single-step MEDIA
SAGE Media	EmbryoScope Plus	SAGE single-step MEDIA
SAGE Media	SAGE MEDIA	SAGE single-step MEDIA
GLOBAL Media	GLOBAL MEDIA	LIFE GLOBAL single-step MEDIA

Primary Outcome Measures

Name	Time	Method
Aneuploidy Rates	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 Outcome Measures

Name	Time	Method
Embryo Quality	2 weeks from start of IVF treatment	Fraction of freezable quality embryos (6 cells or greater, grades 1-2 for symmetry and fragmentation), (%).
Embryo Morphokinetics	2 weeks from start of IVF treatment	time to first and all subsequent cell cleavages
Embryonic Mosaicism	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%.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States