BACKGROUND: The potential effects of hyperandrogenism (HA) on pregnancy outcomes among polycystic ovary syndrome (PCOS) patients are still unknown. The aim of this study was to explore the impact of HA on miscarriage rate after in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment in PCOS patients. METHODS: Women diagnosed with PCOS who underwent the first autologous IVF/ICSI cycles using gonadotropin-releasing hormone agonist (GnRH-a) protocols for ovarian stimulation during the period from January 2016 to December 2022 were included. Women were divided into the HA and non-HA group according to Hyperandrogenemia (serum testosterone level >
0.48 ng/mL), and/or the presence of hirsutism. Pregnancy outcomes were compared before and after propensity-score matching (PSM). Multiple logistic regression models were performed to demonstrate the independent impact of HA on pregnancy outcomes. RESULTS: A total of 3066 patients were included. PCOS women with HA experienced a notably higher rates of late spontaneous miscarriage (LSM) as compared to those without HA before and after PSM (8.8% versus 3.5%, P <
0.002
8.9% versus 3.9%, P = 0.002, respectively), but comparable rates of clinical pregnancy, early spontaneous miscarriage, and live birth. After adjusting for possible confounding factors, the logistic regression confirmed that HA was independently associated with the increased risk of LSM (adjusted OR: 2.540, 95% confidence interval: 1.326-4.672, P = 0.003). For the specific reasons for LSM, cervical insufficiency accounted for a larger proportion in women with HA than their counterparts without HA (15/32 versus 7/33, P = 0.029). CONCLUSIONS: Androgen excess is postulated to play a role in late miscarriage via increased likelihood of cervical insufficiency. TRIAL REGISTRATION: N/A.