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

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

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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