Asparagus racemosus (Shatavari) in Polycystic Ovary Syndrome: An Evidence-Tiered Translational Review from Phytochemistry to Clinical Trials

Abstract

Background/Objectives: Polycystic ovary syndrome (PCOS), renamed polyendocrine metabolic ovarian syndrome (PMOS) in 2026, is a heterogeneous endocrine–metabolic disorder. Asparagus racemosus (Shatavari) is widely used for women’s reproductive health, and placebo-controlled trials in PCOS have now been published. This review grades that evidence. Methods: PubMed, Europe PMC, Scopus, Web of Science and ScienceDirect were searched to 15 October 2026, together with trial registries. Trials were assessed with RoB 2, animal studies with SYRCLE, and certainty of evidence with GRADE. Results: Seven reports were included: three trial reports, three rodent studies and one in vitro/in silico study. Two trial reports (CL22209 and CL22205) share one registration, sponsor and a numerically identical placebo arm, and are best read as two arms of one trial. The clinical evidence therefore comes from two independent data sources, with 160 unique women randomised and 95 allocated to Shatavari for 12 weeks or less. The single-sponsor programme reported reductions in ovarian volume, follicle count, hirsutism score, testosterone and HOMA-IR; the independent trial found no effect on ovarian volume or hormones. No trial improved cycle regularity relative to placebo, and none measured ovulation, pregnancy or live birth. Risk of bias was high or raised some concerns, and certainty was very low for every outcome. Conclusions: Current evidence does not establish a benefit of Shatavari in PCOS. Independent trials with confirmed ovulation, live birth and endometrial safety as prespecified endpoints are needed.