Study design and participants
infertility
DISEASE, COMPLICATIONS, PREGNANCY LOSS
The study design has been reported in detail (The RCT was conducted at 19 reproductive medical centers throughout China between April 2014 and June 2017. The inclusion criteria were: (i) women with infertility aged ≤ 43 years, (ii) body mass index (BMI) under 30, (iii) had intact bilateral ovaries, and (iv) planned to undergo IVF or intracytoplasmic sperm injection (ICSI). The exclusion criteria were: (i) a history of repeated implantation failure (≥ 3 IVF or ICSI-ET cycles); (ii) any disease not suitable for ART or pregnancy (described previously) (Finally, a total of 2265 eligible subjects were enrolled and randomly assigned (1:1) to receive ZYP (n=1131) or placebo (n=1134) at a dose of 5 g orally three times a day. Patients were asked to take medicine from the day of downregulation (long protocol) or from day 19-23 in a previous cycle (antagonist protocol), until the day of the pregnancy test (i.e., 2 weeks after ET). Follow-ups were carried out on the ovulation induction day, embryo transfer day, 2 weeks after transfer, 5 weeks after transfer. A telephone follow-up was performed after delivery. Treatment outcomes including rates of live birth, implantation, biochemical pregnancy, clinical pregnancy, pregnancy loss, cycle cancellation, as well as incidences of maternal, fetal, neonatal complications and neonatal weights were assessed.