Efficacy and safety of hyaluronic acid-enriched transfer medium in women undergoing single blastocyst transfer: a study protocol for a multicentre randomised controlled trial.

INTRODUCTION

EmbryoGlue, a commercially available hyaluronic acid (HA)-enhanced culture medium, is commonly recommended as an adjunct to support embryo implantation. Given the current lack of conclusive evidence regarding its efficacy and safety, this study aims to evaluate the effectiveness and safety of HA-enriched medium in women undergoing in vitro fertilisation (IVF) treatment.

METHODS AND ANALYSIS: This multicentre, patient-blinded, randomised controlled trial involves couples planning a single fresh or frozen blastocyst-stage embryo transfer. On the morning of embryo transfer, individual blastocysts are randomly allocated to either a high-concentration HA medium (EmbryoGlue, 0.5 mg/mL) or a conventional low-concentration HA medium (G-2 PLUS, 0.125 mg/mL). The primary outcome is live birth rate per embryo transfer, with secondary outcomes including biochemical pregnancy rate, clinical pregnancy rate, miscarriage rate, ectopic pregnancy rate, ongoing pregnancy rate, multiple pregnancy rate, as well as obstetric and perinatal outcomes and related complications. The trial plans to enrol 858 female patients from four IVF centres in China, with 429 patients in each group.

ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of Northwest Women's and Children's Hospital (approval no.: 2024-127), and all participating centres have obtained approvals from their respective institutional review boards or ethics committees. Results will be disseminated through publication in a peer-reviewed open-access journal and oral presentations at relevant domestic and international academic conferences.

TRIAL REGISTRATION NUMBER: NCT06492785.