NTR5423.
Trial name or title | Embryo SELECtion using TIme‐lapse MOnitoring in IVF and ICSI patients |
Methods | Multicentre randomised controlled trial |
Participants | Women scheduled for a SET during their first IVF or ICSI cycle at any of the participating IVF centres will be considered for inclusion. |
Interventions | A) embryo selection based on Eeva results and continuous culture in GERI+ incubator (GERI+ Eeva complete), and B) routine embryo selection based on morphology and continuous culture in GERI+ incubator (GERI culture only), will be compared to C) routine embryo selection based on morphology and interrupted culture in GERI+ incubator (control). Embryos in all 3 groups will be cultured in the GERI+ time‐lapse incubator. |
Outcomes | Primary outcomes are the ongoing pregnancy rate of the first fresh SET and the cumulative ongoing pregnancy rate including the first fresh SET and all subsequent cryo transfers from the same ovum pick up cycle within 1 year. Secondary outcomes are biochemical pregnancy rate and live‐birth rate after fresh SET, cumulative live‐birth rate, miscarriage rate, time to pregnancy, embryo morphology and number of useable embryos (i.e. embryos used for transfer or cryopreservation), morphokinetic parameters, pregnancy rates in 3 female age groups, cost efficiency, outcome of manual time‐lapse annotations. |
Starting date | 1 March 2017 |
Contact information | DC Kieslinger: d.kieslinger@vumc.nl |
Notes |
COS: controlled ovarian stimulation E2: estradiol FSH: follicle‐stimulating hormone ICSI: intracytoplasmic sperm injection IU: international unit IVF: in vitro fertilisation mIU: milli‐international unit SET: single embryo transfer 2PN: 2 pronuclei