Clinical Research Directory

Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium

Sponsor: Azienda Sanitaria Locale di Asti

Summary

Endometrial receptivity is a key determinant of success in assisted reproductive technology (ART). A significant proportion of patients experience repeated implantation failure despite euploid embryos and adequate laboratory conditions. Thin endometrium, often defined as ultrasound-measured thickness \<7 mm at embryo transfer, is frequently refractory to estrogen therapy and associated with low implantation and clinical pregnancy rates. Platelet-Rich Plasma (PRP), obtained from autologous blood by double centrifugation, is rich in growth factors capable of stimulating cell proliferation, angiogenesis, and tissue regeneration, suggesting potential benefits for endometrial function. Preliminary studies indicate improved endometrial thickness and reproductive outcomes following intrauterine PRP infusion, but standardized protocols and systematic data are lacking. The PMA\_PREPAIRE study is a prospective, single-center interventional clinical trial with a retrospective comparison group, conducted at the Reproductive Medicine Center of Cardinal Massaia Hospital, Asti. It aims to evaluate the efficacy of intrauterine infusion of autologous PRP in improving endometrial receptivity and reproductive outcomes in women with thin or refractory endometrium undergoing hormone replacement therapy (HRT). Eligible women will be treated with standard clinical care, with PRP infusion offered to those with insufficient response to HRT. Inclusion criteria include age 18-45, BMI 18-30 kg/m², history of ≥1 failed embryo transfer, EMT \<5 mm after ≥10 days of HRT, and normal routine lab tests. Exclusion criteria include endometrial disease, recent gynecological infection, and systemic conditions such as thrombocytopenia or coagulopathies. Procedures include standard HRT from cycle days 1-2, serial ultrasound monitoring of endometrial thickness from days 6-8, intrauterine PRP infusion if EMT ≤7 mm (up to three infusions per cycle), embryo transfer once EMT ≥7 mm, and follow-up through pregnancy testing and confirmatory ultrasound. Collected data will be analyzed with descriptive statistics, paired t-tests for pre/post PRP EMT comparison, and logistic regression to evaluate predictors of success (significance p \< 0.05). A sample size of 34 patients per arm is estimated to detect a 1.5 mm change in EMT with 90% power; with 15% dropout anticipated, 40 patients per group will be enrolled. The retrospective control group consists of 40 historical patients with refractory thin endometrium treated without PRP.

Official title: PMA_PREPAIRE STUDY: Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium.

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