Media, Morphokinetics, and Mosaicism

Infertility Clinical Trial

— 3M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503877
• Other study ID #: 17-22331
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: November 28, 2019

Study information

• Verified date: November 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 28, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Culture Media
• Embryo Morphokinetics
• Embryonic Mosaicism
• Infertility

Intervention

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

Other:
• GLOBAL MEDIA
Embryos will be cultured in GLOBAL media
• SAGE MEDIA
Embryos will be cultured in SAGE media

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
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%.	Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment
Secondary	Embryo Morphokinetics	time to first and all subsequent cell cleavages	2 weeks from start of IVF treatment