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Clinical Trials/NCT03503877
NCT03503877
Completed
Not Applicable

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

University of California, San Francisco1 site in 1 country200 target enrollmentFebruary 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Embryonic Mosaicism
Sponsor
University of California, San Francisco
Enrollment
200
Locations
1
Primary Endpoint
Aneuploidy Rates
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2018
End Date
November 28, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Embryo Quality(2 weeks from start of IVF treatment)
  • Embryo Morphokinetics(2 weeks from start of IVF treatment)
  • Embryonic Mosaicism(Preimplantation Genetic Testing at blastocyst stage of embryo development, 2 weeks from start of IVF treatment)

Study Sites (1)

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