Media, Morphokinetics, and Mosaicism

NCT03503877 | Completed Results DMC FDA Device

• 1 other identifier: 17-22331
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Embryonic Mosaicism; Embryo Culture Media; Embryo Morphokinetics; Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Embryo Quality

  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

• Embryo Morphokinetics

  2 weeks from start of IVF treatment

Study Arms (2)

SAGE Media

OTHER

SAGE single-step MEDIA

Device: EmbryoScope Plus; Other: SAGE MEDIA

GLOBAL Media

OTHER

LIFE GLOBAL single-step MEDIA

Device: EmbryoScope Plus; Other: GLOBAL MEDIA

Interventions

EmbryoScope Plus DEVICE

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

GLOBAL Media; SAGE Media

GLOBAL MEDIA OTHER

Embryos will be cultured in GLOBAL media

GLOBAL Media

SAGE MEDIA OTHER

Embryos will be cultured in SAGE media

SAGE Media

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Female partner age \>42 years of age Cleavage stage biopsy

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Fetoscopes

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Limitations and Caveats

A limitation of our study is the absence of long-term outcome data including pregnancy outcomes and offspring health data

Results Point of Contact

• Title: Mitchell Rosen
• Organization: University of California, San Francisco

Mitchell.Rosen@ucsf.edu

415-353-7475

Study Officials

• Mitchell Rosen, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: sibling embryo study

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: April 20, 2018
• Study Start: February 14, 2018
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: December 14, 2022
• Results First Posted: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)