The effect of growth hormone on the euploid rate of blastocysts in patients with advanced maternal age: study protocol for a single-blinded randomized controlled trial.

backgroundWomen with advanced maternal age (AMA) face a significant decline in embryo euploidy rates, leading to reduced fertility and increased risks of adverse pregnancy outcomes. While preimplantation genetic testing for aneuploidy (PGT-A) aids in selecting euploid embryos, it does not address the underlying causes of aneuploidy. Growth hormone (GH) has shown promise in improving oocyte quality and embryo development, but its impact on the euploidy status of embryos remains underexplored. This randomized controlled trial aims to evaluate the effect of GH supplementation on the euploidy rate of blastocysts in AMA patients.

methodsA total of 400 women with AMA undergoing PGT-A will be randomized into two groups: the GH group (GnRH antagonist protocol with daily subcutaneous injection of 2 IU GH starting from the previous menstrual cycle) and the control group (GnRH antagonist protocol without GH). Embryos will be cultured in time-lapse monitoring (TLM), and morphokinetic parameters will be recorded. Trophectoderm biopsies will be analyzed using next-generation sequencing-based PGT-A to determine ploidy status. The primary outcome is the euploidy rate of blastocysts, while secondary outcomes include embryo developmental and morphokinetic parameters, as well as pregnancy outcomes after transfer. DISCUSSION: This prospective, single-center RCT will investigate the impact of GH supplementation on euploidy rates, morphokinetic parameters, and transfer outcomes in AMA patients. By combining PGT-A and TLM with randomization and blinding, the study will minimize bias and provide robust insights into how GH may improve reproductive outcomes in AMA women, offering high-quality clinical evidence for ART practice. TRIAL REGISTRATION NUMBER: NCT05447208, www.clinicaltrials.gov . Registered on July 3rd, 2022.