Clinical secondary outcomes
| Clinical outcomes | Definition |
|---|---|
| Live birth rate | Birth of a live baby after 24 weeks gestation |
| Miscarriage rate | Loss of a diagnosed clinical pregnancy before 20 weeks gestation |
| Sleepiness score | Based on Karolinska56 sleepiness scale during trial medication administration |
| Pregnancy complication and adverse events rates | Including OHSS, multiple pregnancy, congenital or chromosomal abnormalities, stillbirth, pre-eclampsia, delivery before 34 weeks, delivery between 34 and 37 weeks, placenta praevia, gestational diabetes, low birth weight |
| Embryological outcomes | |
| Total number of oocytes collected | |
| Oocyte maturity | |
| Total number of embryos | |
| Embryo quality | |
| Fertilisation rate | The proportion of oocytes that become fertilised |
| Utilisation rate | Proportion of zygotes undergoing embryo transfer or cryopreservation to oocytes fertilised |
| Biochemical outcomes | |
| Biochemical pregnancy rate | Presence of serum hCG level of >25 IU/L on day 16 after embryo transfer |
| Melatonin levels in serum | At baseline and prior to oocyte collection |
| Melatonin levels in follicular fluid | Taken from leading follicle from each ovary at time of oocyte collection |
| 8-OHdg levels in serum | At baseline and prior to oocyte collection |
| 8-OHdg levels in follicular fluid | Taken from leading follicle from each ovary at time of oocyte collection |
| Oestradiol and progesterone levels in serum | Taken at baseline, during treatment and at the time of oocyte collection |
| Sonographic outcomes | |
| Follicular blood flow | Measured on last transvaginal ultrasound with power Doppler prior to oocyte collection |
| Uterine artery blood flow | Measured on last transvaginal ultrasound with power Doppler prior to oocyte collection |
hCG, human chorionic gonadotropin; OHSS, ovarian hyperstimulation syndrome; 8-OHdg, 8-hydroxy-2′-deoxyguanosine.