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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-step medium | Experimental | embryos will be cultured in a single-step medium for 5 days with no change |
|
| Control | Other | Embryos cultured in two Culture media for 5 Days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-step medium | Device | This medium will allow in vitro culture of human embryos for 5/6 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of good quality blastocysts | 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. | 5 days of in vitro embryo culture |
| Measure | Description | Time Frame |
|---|---|---|
| % GQE DAY 3 | Percentage of good quality embryos on day 3 of development | Measured 3 days after oocyte pick-up |
| Blast. Utilization rate | Number of blastocyst that are cryopreserved or transfered on either day 5 or 6 of embryo development. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorir Hardarson, PhD | Fertilitetscentrum AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Fertility Center | San Francisco | California | 94133 | United States | ||
| Frisco IVF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26409153 | Derived | 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. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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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.
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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.
| Standard culture medium | Device | This culture system needs media change on day 3 of culture. |
|
| Measured 5 and 6 days after oocyte pick-up |
| Blast. rate | Number of embryos reaching the blastocyts stage on either day 5 or day 6. | Measured 5 and 6 days after oocyte pick-up. |
| Frisco |
| Texas |
| 75034 |
| United States |
| Fertilitetscentrum | Gothenburg | 40229 | Sweden |
| Skanes University Hospital | Malmö | 20502 | Sweden |