Comparative analysis of the use of autologous exosomes and platelet-derived growth factors in women with premature ovarian insufficiency and infertility: A prospective, randomized, observational, analytical study

自体外泌体与血小板衍生生长因子治疗卵巢早衰和不孕症女性的疗效比较分析:一项前瞻性、随机、观察性、分析性研究

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Abstract

Stromal fibrosis and ovarian aging depend not only on the age of the patients but also on environmental factors, lifestyle and physiological events such as ovulation itself, which leaves repeated scarring in the ovarian stroma, limiting normal tissue vascularization and the provision of biological signals necessary to maintain folliculogenesis and hormone synthesis. In a fibrosed ovarian stroma, there is a decrease in hyaluronic acid concentrations, loss of synthesis and migration proteins, a decrease in microRNAs, in addition to enzymatic alterations that affect mitochondrial kinases, increasing oxygen free radicals, which accelerate cell death. OBJECTIVES: This study seeks to analyze the effectiveness of autologous exosomes in reversing aging and bioregenerating the ovary of patients with ovarian failure and infertility by improving interstitial fibrosis and providing the necessary elements to activate neofolliculogenesis. METHODOLOGY: Prospective, randomized, comparative study in 30 women between 38 and 46 years old, with diminished ovarian reserve and who rejected the egg donation procedure. Three study groups composed of 10 patients each: the first with autologous exosomes, the second with PRP and the third with saline solution. RESULTS: After completing the study, it was found that women in the Autologous Exosome group showed better ovarian reserve parameters such as FSH, LH, Estradiol, Anti-Müllerian Hormone and antral follicle count, edema of more oocytes collected in Metaphase II, higher fertilization rate, frozen embryos and positive pregnancies. CONCLUSION: Ovarian Biostimulation with Autologous Exosomes could be considered a safe and promising therapy to improve markers of low ovarian reserve. TRIAL REGISTRATION: Clinical Trials.gov. Registration Number: NCT06773572. URL: Study Details | Use of Autologous Exosomes vs Platelet Growth Factors to Regenerate the Ovary in Women With Infertility (Exosomas2024-1) | ClinicalTrials.gov.

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