Effect of orlistat and anti-androgen oral contraceptives on pregnancy outcomes in overweight or obese PCOS patients during comprehensive management.

OBJECTIVE

To investigate the impact of comprehensive preconception management using combined oral contraceptives (COCs) and orlistat on live birth rates and pregnancy outcomes in overweight or obese women with polycystic ovary syndrome (PCOS), aimed at optimizing preconception management strategies.

METHODS

This prospective cohort study enrolled 235 overweight or obese PCOS women aged 20-40 years. Participants were categorized into three preconception management groups: a DRSP/EE monotherapy group (n = 37), a DRSP/EE + orlistat combination therapy group (n = 71), and a non-medication control group (n = 127). All groups received individualized comprehensive management. The primary outcomes were live birth rate and incidence of pregnancy complications, including gestational diabetes mellitus (GDM) and hypertensive disorders of pregnancy (HDP). Secondary outcomes encompassed adverse pregnancy outcomes (APO), cesarean section rate, and neonatal complications.

RESULTS

The incidence of GDM was significantly lower in the combination therapy group (31.9%) compared to the control group (56.6%) (P < 0.01). The DRSP/EE monotherapy group (33.3%) showed a decreasing trend, but statistical significance was not maintained after adjustment for multiple comparisons. While no statistically significant differences were observed in HDP, live birth rates, or APO among the groups (P > 0.05), the combination group exhibited the most favorable trends, achieving the highest live birth rate (97.2%) and the lowest APO rate (21.1%) compared to the monotherapy and control groups. Similarly, neonatal outcomes (preterm delivery, low birth weight, macrosomia) were comparable across groups, though the combination group showed numerically lower rates of preterm delivery and macrosomia. Multivariable logistic regression identified body mass index (BMI), fasting plasma glucose (FPG), fasting insulin (FINS), and total testosterone (TT) as independent risk factors for GDM, whereas both medication regimens were identified as significant protective factors.

CONCLUSION

This study demonstrates that preconception combination therapy with DRSP/EE and orlistat significantly reduces the risk of GDM in overweight or obese women with PCOS. DRSP/EE monotherapy also exhibits a potential protective trend, although the effect is less robust compared to the combination regimen. While differences in HDP and other pregnancy outcomes did not reach statistical significance, the combination therapy group yielded the most favorable clinical profile, achieving the numerically highest live birth rate and the lowest incidence of adverse pregnancy outcomes. Comprehensive management targeting BMI and metabolic indicators is crucial for improving pregnancy prognosis in this population.