Infertility
Conditions
Keywords
embryo, culture
Brief summary
The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.
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.
Interventions
DEVICESingle-step medium
This medium will allow in vitro culture of human embryos for 5/6 days
DEVICEStandard culture medium
This culture system needs media change on day 3 of culture.
Sponsors
Vitrolife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of good quality blastocysts | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % GQE DAY 3 | Measured 3 days after oocyte pick-up | Percentage of good quality embryos on day 3 of development |
| Blast. Utilization rate | 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. |
| Blast. rate | Measured 5 and 6 days after oocyte pick-up. | Number of embryos reaching the blastocyts stage on either day 5 or day 6. |
Countries
Sweden, United States
Outcome results
None listed