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

V

Vitrolife

Status

Completed

Conditions

Infertility

Treatments

Device: Standard culture medium
Device: Single-step medium

Study type

Interventional

Funder types

Industry

Identifiers

NCT01939626
TL-SCM-2013

Details and patient eligibility

About

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

Full 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.

Enrollment

128 patients

Sex

Female

Ages

21 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

128 participants in 2 patient groups

Single-step medium
Experimental group
Description:
embryos will be cultured in a single-step medium for 5 days with no change
Treatment:
Device: Single-step medium
Control
Other group
Description:
Embryos cultured in two Culture media for 5 Days.
Treatment:
Device: Standard culture medium

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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