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

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.

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.

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.

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.

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.

Number of blastocyst that are cryopreserved or transfered on either day 5 or 6 of embryo development.

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

Hardarson T, Bungum M, Conaghan J, Meintjes M, Chantilis SJ, Molnar L, Gunnarsson K, Wikland M. Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup. Fertil Steril. 2015 Dec;104(6):1452-9.e1-4. doi: 10.1016/j.fertnstert.2015.08.037. Epub 2015 Sep 25.