Comparison of Human Embryo Development Using Sequential and Single Media With Time-lapse Imaging

January 8, 2021 updated by: Vitrolife

Comparison of Human Embryonic Development Using Sequential and Single Media in IVF Monitored by Time-lapse Imaging.

The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media.

Design: Randomized, double-blinded sibling trial. Setting: Independent in vitro fertilization (IVF) clinics. Patient(s): One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms.

Intervention(s): Embryos from each patient were randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Goteburg, Sweden, 40229
        • Fertilitetscentrum
      • Malmo, Sweden, 20502
        • Skånes University Hospital
  • United States
    • California
      • San Francisco, California, United States, 94133
        • Pacific Fertility Center
    • Texas
      • Frisco, Texas, United States, 75034
        • Frisco IVF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 6 or more normal embryos following egg retrieval and fertilization.
  • Female patients aged 21-40 years or 21-55 years who are using an egg donor.
  • Patients using fresh or frozen ejaculated sperm

Exclusion Criteria:

  • Previous history of cancer
  • Day 3 embryo transfer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-step medium
embryos will be cultured in a single-step medium for 5 days with no change
Device: Single-step medium
This medium will allow in vitro culture of human embryos for 5/6 days
Other Names:
  • Single step culture medium
Other: Control
Embryos cultured in two Culture media for 5 Days.
Device: Standard culture medium
This culture system needs media change on day 3 of culture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of good quality blastocysts
Time Frame: 5 days of in vitro embryo culture
A cohort of human embryos will be divided into two different media. The ability of the media to support human embryo development will be determined using the standard assessment of the percentage of embryos that achieve a defined embryo grade.
5 days of in vitro embryo culture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% GQE DAY 3
Time Frame: Measured 3 days after oocyte pick-up
Percentage of good quality embryos on day 3 of development
Measured 3 days after oocyte pick-up
Blast. Utilization rate
Time Frame: Measured 5 and 6 days after oocyte pick-up
Number of blastocyst that are cryopreserved or transfered on either day 5 or 6 of embryo development.
Measured 5 and 6 days after oocyte pick-up
Blast. rate
Time Frame: Measured 5 and 6 days after oocyte pick-up.
Number of embryos reaching the blastocyts stage on either day 5 or day 6.
Measured 5 and 6 days after oocyte pick-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitrolife

Investigators

  • Principal Investigator: Thorir Hardarson, PhD, Fertilitetscentrum AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TL-SCM-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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