ACTRN12616000643471

Trial name or title	Comparison of the probability of live birth after elective freezing of all embryos versus standard fresh embryo transfer in patients undergoing in‐vitro fertilisation (IVF)
Methods	RCT Target enrolment: 400
Participants	Women aged 18 to 39 with indication for COS and IVF or ICSI with autologous gametes Key inclusion criteria: Age: 18 to 39 years BMI: 18 to 32 kg/m2 Presence of both ovaries Normal menstruating cycles: 21 to 35 days Cycle where prevention of premature LH rise is achieved using a GnRH antagonist 8 to 19 follicles ≥ than 10 mm in mean diameter on the day of triggering Key exclusion criteria: Endometriosis stage > II Indication for PGD/PGS History of OHSS Previous participation in the RCT > 3 previous unsuccessful stimulated cycles History of hypothalamic dysfunction or history of inadequate pituitary response to GnRH agonist triggering
Interventions
Outcomes	Live birth after the transfer of the first embryo: delivery of a live baby after the 20th week of gestation Ongoing pregnancy diagnosed by ultrasonography as presence of foetal heart activity at 10 to 12 weeks of gestation Clinical pregnancy diagnosed by ultrasound as presence of foetal heart activity at 6 to 8 weeks of gestation First trimester miscarriage, defined as a biochemical pregnancy (assessed by serum hCG) at 11 to 16 days after embryo transfer but no foetal heart activity at 10 to 12 weeks of gestation as assessed by ultrasonography Occurrence of severe OHSS Preterm labour (defined as delivery < 37 weeks of gestation) Mode of delivery (normal vaginal delivery, assisted vaginal delivery, Caesarean section) Neonatal birth weight Stillbirth Neonatal mortality Death within the first 28 days of life Intrauterine growth restriction Hypertensive disorders of pregnancy (including gestational hypertension, pre‐eclampsia, eclampsia) Gestational diabetes mellitus
Starting date	May 2016
Contact information	Christos Venetis: c.venetis@unsw.edu.au
Notes	www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12616000643471