Intra-ovarian injection of platelet-rich plasma in patients with poor ovarian response; a randomized controlled clinical trial

BACKGROUND: There is a clear need for new approaches to help women with low ovarian reserve. A new intervention for women with low ovarian reserve is the intra-ovarian injection of platelet-rich plasma (PRP). It is important to comprehensively evaluate the safety and efficacy of newly introduced treatments before they are used in clinical settings. This randomized controlled clinical trial (RCT) aimed to determine the effect of intra-ovarian PRP injection in patients with a history of poor ovarian response (POR). METHODS: In this RCT were included a total of 200 infertile women from February 2023 to July 2024. Inclusion criteria including infertile women with a history of POR; age < 43 years; body mass index < 35 Kg/m2; follicle-stimulating hormone < 20 IU/mL; anti-mullerian hormone (AMH) < 1.2 ng/mL. The participants were randomly assigned to the two groups with and without Intra-ovarian PRP injection according to a computer-generated, unconcealed randomization list. The primary outcome was an increase in ovarian reserve. All patients were followed for one year. RESULTS: There were no significant differences in serum AMH level. The antral follicle count (AFC) was significantly higher in intervention group (p = 0.001). The intervention group demonstrated significantly higher oocyte maturation rate (p = 0.005) and fertilization rate (p = 0.018). The number of high-quality embryos was significantly greater in the intervention group (p = 0.042). In the intervention group, 10.5% of patients achieved spontaneous pregnancy within 3–8 months after intra-ovarian PRP injection. The clinical pregnancy rate following fresh embryo transfer (ET) was significantly higher in the intervention group (p = 0.024). Rates of miscarriage, preterm labor, and pregnancy complications were comparable between groups. CONCLUSIONS: Our study demonstrated that the injection of 3 mL PRP with a fivefold platelet concentration compared to baseline serum resulted in increased AFC, reduced ovarian stimulation cancellations, and improved quantitative and qualitative parameters of oocytes and embryos. In addition, intra-ovarian PRP was associated with a considerable rate of spontaneous pregnancy and pregnancy after fresh ET, without significantly increasing rates of pregnancy complications. Despite the strengths of the present study, we still have a rudimentary knowledge of the PRP platform and related elements of this innovative approach. Addressing these shortcomings requires conducting basic studies to resolve the unclear points of this issue. TRIAL REGISTRATION: This study prospectively registered in http://www.Iranian Registry of Clinical Trials.ir (ID: IRCT20080831001141N40) at 01/17/2023.