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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was a two-arm, prospective, randomized, controlled clinical trial performed at four independent IVF clinics. Ovarian stimulation and oocyte collection and fertilization were performed as per each clinic's practice. If \>6 oocytes from the patient were fertilized, the resulting zygotes underwent stratified randomization into the two different media.

Allocation was performed in a 1:1 ratio according to a computer-generated randomization list for each couple, which was provided in sealed and numbered envelopes to each clinic.

Zygotes randomized into G-1/G-2 underwent a media change from G-1 to G-2 on day 3 and subsequent culture until days 5-6. The zygotes randomized to G-TL were cultured continuously without any media change until days 5-6.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

To minimize the possible bias for the primary outcome, the embryologist performing the morphologic evaluation on day 3 and 5-6 was blinded to the treatments. The physician, the embryologist, and the couple were also blinded to the culture group from which the embryo had been selected for transfer.

Study Groups

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Single-step medium

embryos will be cultured in a single-step medium for 5 days with no change

Group Type EXPERIMENTAL

Single-step medium

Intervention Type DEVICE

This medium will allow in vitro culture of human embryos for 5/6 days

Control

Embryos cultured in two Culture media for 5 Days.

Group Type OTHER

Standard culture medium

Intervention Type DEVICE

This culture system needs media change on day 3 of culture.

Interventions

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Single-step medium

This medium will allow in vitro culture of human embryos for 5/6 days

Intervention Type DEVICE

Standard culture medium

This culture system needs media change on day 3 of culture.

Intervention Type DEVICE

Other Intervention Names

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Single step culture medium

Eligibility Criteria

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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