Abstract
BACKGROUND: Oocyte aneuploidy is a major cause of pregnancy failure in women of advanced maternal age (AMA), and current assisted reproductive technologies offer limited effective strategies to prevent age-related decline in oocyte quality. The mevalonate (MVA) pathway in granulosa cells has recently been implicated in supporting meiotic maturation, but its therapeutic potential in humans remains unclear. This randomized controlled trial is designed to evaluate the effects of MVA supplementation on oocyte competence in women of AMA undergoing preimplantation genetic testing for aneuploidy (PGT-A). METHODS: The study will be conducted as a single-center, prospective, randomized controlled trial. A total of 128 infertile women aged 38-42 years undergoing PGT-A will be enrolled and randomized to either the MVA supplementation group or the control group. Cumulus-oocyte complexes retrieved from each cycle will be allocated according to the randomization protocol, with an estimated 150 cycles analyzed. The primary outcome is the euploidy blastocyst rate, while the secondary outcomes are the clinical pregnancy rate and live birth rate following frozen embryo transfer (FET). DISCUSSION: This trial is expected to evaluate the effects of MVA supplementation on euploidy blastocyst rate and clinical pregnancy outcomes in women of AMA undergoing PGT-A. These findings may provide valuable insights into the potential application of MVA supplementation as an adjunct treatment for infertility in this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05788822. Registered in March 2023.