Intrauterine infusion of autologous platelet-rich plasma (PRP) versus granulocyte colony-stimulating factor (G-CSF) prior to single frozen blastocyst transfer in women with thin endometrium: a study protocol for a multicentre sequential multiple assignment randomised trial
Abstract
Introduction: A thin endometrium (TE) is associated with reduced reproductive potential, including lower implantation rates and increased obstetric risks. While intrauterine infusion of autologous platelet-rich plasma (PRP) or granulocyte colony-stimulating factor (G-CSF) is commonly used, robust evidence for their efficacy remains lacking. This trial aims to compare the effectiveness of PRP versus G-CSF in women with TE using a sham-controlled, sequential multiple assignment randomised trial (SMART) design.
Methods and analysis: This is a triple-blind, multicentre SMART study conducted at four tertiary fertility centres in China. We will recruit 440 women undergoing single frozen blastocyst transfer with a history of TE (endometrial thickness <8 mm). Participants will be randomly assigned (1:1:2) to receive intrauterine infusion of PRP, G-CSF or a sham procedure (stage 1). Infusions are performed twice per cycle: when the leading follicle reaches 13-14 mm in natural frozen embryo transfer (FET) cycles or stimulated FET cycles, or on day 8 of oestradiol administration in artificial FET cycles, repeated 48 hours later. The primary outcome is the live birth rate from the first embryo transfer (Stage 1). Secondary outcomes include changes in endometrial thickness, clinical pregnancy rates and neonatal outcomes. Participants in the sham group who do not achieve a live birth will be re-randomised (1:1) to receive either PRP or G-CSF for their subsequent transfer (Stage 2). Data…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 440 participants or records.
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