MedDataX Logo

Media, Morphokinetics, and Mosaicism

NCT ID: NCT03503877

Last Updated: 2022-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2019-11-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Embryonic Mosaicism Embryo Culture Media Embryo Morphokinetics Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

sibling embryo study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAGE Media

SAGE single-step MEDIA

Group Type OTHER

EmbryoScope Plus

Intervention Type DEVICE

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

SAGE MEDIA

Intervention Type OTHER

Embryos will be cultured in SAGE media

GLOBAL Media

LIFE GLOBAL single-step MEDIA

Group Type OTHER

EmbryoScope Plus

Intervention Type DEVICE

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

GLOBAL MEDIA

Intervention Type OTHER

Embryos will be cultured in GLOBAL media

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EmbryoScope Plus

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

Intervention Type DEVICE

GLOBAL MEDIA

Embryos will be cultured in GLOBAL media

Intervention Type OTHER

SAGE MEDIA

Embryos will be cultured in SAGE media

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mitchell Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California San Francisco

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17-22331

Identifier Type: -

Identifier Source: org_study_id