Table I.
Secondary endpoints and their definition.
| Secondary endpoint | Definition |
|---|---|
| Fertility outcomes | |
| Fertilisation rate per oocyte inseminated/injected | Fertilisation is defined as the appearance of two PN at 18–20 h per inseminated/injected |
| Fertilisation rate per oocyte retrieval | Fertilisation is defined as the appearance of two PN at 18–20 h per oocyte retrieved |
| Abnormal fertilisation rate | Abnormal fertilisation rate is defined as the appearance of three PN at 18–20 h after oocyte retrieved and inseminated/injected |
| Total fertilisation failure rate | Total fertilisation failure rate is defined as the absence of any zygotes with 2PN at 18–20 h after oocyte retrieved and inseminated/injected |
| Embryos on Day 3 | Number of embryos on Day 3 after oocyte retrieval day in IVF/ICSI |
| Good quality embryo on Day 3 | Numbers of embryos on Day 3 with good quality after oocyte retrieval day in IVF/ICSI |
| Embryo freezing on Day 3 | Number of embryo freezing on Day 3 after oocyte retrieval day in IVF/ICSI |
| Live birth from all embryos from the started treatment cycle | Live birth is defined as the birth of at least one newborn after 24 weeks' gestation that exhibits any sign of life (twin will be a single count) |
| Positive pregnancy test | Positive pregnancy test is defined as a serum hCG level greater than 25 mIU/mL 14 days after the first transfer |
| Clinical pregnancy | Clinical pregnancy is defined as the presence of at least one gestational sac on ultrasound at 7 weeks’ gestation with the detection of heart beat activity, after the completion of the first transfer |
| Ongoing pregnancya | Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks’ gestation or beyond, after the completion of the first transfer |
| Implantation rate | Implantation rate is defined as the number of gestational sacs per number of embryos transferred 3 weeks after the first transfer |
| Time from randomisation to ongoing pregnancy | Time from randomisation to ongoing pregnancy after completion of the first transfer |
| Maternal safety | |
| OHSS | Symptoms of OHSS At 10 days after hCG injection and 14 days after embryo transfer |
| Pregnancy complicationsa | |
| Ectopic pregnancy | Ectopic nidation of a pregnancy confirmed by sonography or laparoscopy at 12 weeks of gestation |
| Miscarriage | Complete loss of clinical pregnancy at 24 weeks of gestation |
| Multiple pregnancy rate | Multiple pregnancy rate is explained as two or more gestational sacs or positive heart beats by transvaginal sonography 5 weeks after embryo placement |
| Multiple delivery | Multiple delivery is defined as birth of more than one baby beyond 24 weeks |
| Obstetric and perinatal complicationsa | |
| Gestational age at delivery | Gestational age at delivery |
| Gestational diabetes mellitus | Development of diabetes during pregnancy |
| Hypertensive disorders of pregnancy | Hypertensive disorders of pregnancy will include pregnancy induced hypertension, pre-eclampsia and eclampsia at birth |
| Antepartum haemorrhage | Antepartum haemorrhage will include placenta previa, placenta accreta and unexplained |
| Preterm delivery | Preterm delivery is defined as any delivery at < 24, < 28, < 32, < 37 completed weeks' gestation |
| Spontaneous preterm birth | Spontaneous preterm birth is defined as delivery spontaneously at < 24, < 28, < 32, < 37 completed weeks |
| Iatrogenic preterm birth | Iatrogenic preterm birth is defined as delivery non-spontaneously at < 24, < 28, < 32, < 37 completed weeks |
| Birth weight | Weight of newborn |
| Low birthweight | Low birthweight is defined as < 2500 gm at birth |
| Very low birthweight | Very low birthweight defined as < 1500 gm at birth |
| High birthweight | High birthweight is defined as > 4000 gm at birth |
| Very high birthweight | Very high birthweight is defined as > 4500 gm at birth |
| Large for gestational age | Large for gestational age is defined as birthweight > 90th percentile |
| Small for gestational age | Small for gestational age is defined as birthweight < 10th percentile |
| Neonatal complicationa | |
| Congenital anomaly diagnosed at birth | Any congenital anomaly will be included at birth |
| Admission to NICU | The admittance of the newborn to NICU At 7 days after birth |
aAll assessed after completion of the first transfer and at 12 months after randomisation.
OHSS, ovarian hyperstimulation syndrome; NICU, neonatal intensive care unit.