Journal of assisted reproduction and genetics · 2025
Intrauterine platelet-rich plasma infusion for recurrent implantation failure: a pilot randomized controlled single-blinded clinical trial in the USA.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Aghajanova Lusine, Strug Michael, Zhang Jiaqi, Lathi Ruth B
Аннотация
PURPOSE: To evaluate the feasibility and potential therapeutic effect of intrauterine platelet-rich plasma (PRP) infusion in patients with recurrent implantation failure (RIF) undergoing frozen embryo transfer (FET); to characterize PRP cytokine/growth factor profiles by cycle phase and pregnancy outcomes.
METHODS: In this single-blinded, pilot randomized controlled trial, 52 women with unexplained RIF, normal uterine cavity, and endometrial thickness > 7 mm were enrolled. Eleven did not complete the FET cycle, leaving 33 patients in the intention-to-treat analysis (PRP: n = 13; control: n = 20). Eight additional patients received PRP in a subsequent cycle. Participants were randomized to intrauterine PRP or saline infusion in the follicular phase (cycle day 9-12 or days 10-14 of estradiol) and luteal phase (2 days before FET). PRP was isolated from autologous peripheral blood, and 1 mL was infused. Standard treatments were continued. PRP cytokine profiling was performed via Luminex analysis.
PRIMARY OUTCOME: pregnancy rate (PR). Secondary: clinical PR, miscarriage rate (MR), live birth rate (LBR), and cytokine correlations.
RESULTS: Baseline and embryo-related variables were similar between groups. In the intention-to-treat analysis, PR was 69% in the PRP group vs 50% in controls (p = 0.27); LBR was 46% vs 25% (p = 0.27); MR was 22% vs 50% (p = 0.35). PRP was well tolerated. Eight cytokines differed by cycle phase. Lower luteal levels of CCL1, CCL26, and IL-23 correlated with live birth; higher CCL1 and CCL26 correlated with miscarriage.
CONCLUSION: While not statistically significant, PRP showed trends toward improved outcomes in RIF and was safe. Cytokine profiles varied by cycle phase and may reflect markers of fertility or treatment response.
TRIAL REGISTRATION: The study was prospectively registered in the ClinicalTrials.gov Protocol Registration System (NCT03379649, https://clinicaltrials.gov/search?locStr=Sunnyvale,%20CA&country=United%20States&state=California&city=Sunnyvale&cond=Recurrent%20Implantation%20Failure&intr=Platelet%20Rich%20Plasma ). The study was activated on 01/16/2019 and closed on 12/20/2023. The first patient was enrolled on 1/20/2019 and last patient was enrolled on 1/25/2023.
METHODS: In this single-blinded, pilot randomized controlled trial, 52 women with unexplained RIF, normal uterine cavity, and endometrial thickness > 7 mm were enrolled. Eleven did not complete the FET cycle, leaving 33 patients in the intention-to-treat analysis (PRP: n = 13; control: n = 20). Eight additional patients received PRP in a subsequent cycle. Participants were randomized to intrauterine PRP or saline infusion in the follicular phase (cycle day 9-12 or days 10-14 of estradiol) and luteal phase (2 days before FET). PRP was isolated from autologous peripheral blood, and 1 mL was infused. Standard treatments were continued. PRP cytokine profiling was performed via Luminex analysis.
PRIMARY OUTCOME: pregnancy rate (PR). Secondary: clinical PR, miscarriage rate (MR), live birth rate (LBR), and cytokine correlations.
RESULTS: Baseline and embryo-related variables were similar between groups. In the intention-to-treat analysis, PR was 69% in the PRP group vs 50% in controls (p = 0.27); LBR was 46% vs 25% (p = 0.27); MR was 22% vs 50% (p = 0.35). PRP was well tolerated. Eight cytokines differed by cycle phase. Lower luteal levels of CCL1, CCL26, and IL-23 correlated with live birth; higher CCL1 and CCL26 correlated with miscarriage.
CONCLUSION: While not statistically significant, PRP showed trends toward improved outcomes in RIF and was safe. Cytokine profiles varied by cycle phase and may reflect markers of fertility or treatment response.
TRIAL REGISTRATION: The study was prospectively registered in the ClinicalTrials.gov Protocol Registration System (NCT03379649, https://clinicaltrials.gov/search?locStr=Sunnyvale,%20CA&country=United%20States&state=California&city=Sunnyvale&cond=Recurrent%20Implantation%20Failure&intr=Platelet%20Rich%20Plasma ). The study was activated on 01/16/2019 and closed on 12/20/2023. The first patient was enrolled on 1/20/2019 and last patient was enrolled on 1/25/2023.