The outcome of ovarian rejuvenation by PRP in Poor responder patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- AFC(antral follicle count), number of oocytes retrieved, M2 (mature)oocytes, Fertilization Rate, Blastocyst Formation Rate, and Clinical Pregnancy Rate.
研究概览
简要总结
Poor ovarian reserve (POR) is a challenging condition in assisted reproductive technology (ART), with a reported prevalence of 9 to 24 percent among women undergoing in vitro fertilization (IVF), depending on the diagnostic criteria applied. Affected individuals typically present with reduced oocyte yield, compromised embryo quality, and markedly lower live birth rates, which in severe cases may be as low as 2 to 8 percent per cycle. Existing treatment strategies, including high-dose gonadotropins and various adjuvant therapies, have demonstrated limited and inconsistent success in improving outcomes. Consequently, there is a pressing need for novel, evidence-based interventions to support this patient population. Intraovarian injection of autologous platelet-rich plasma (PRP) has recently gained attention as a potential regenerative therapy. PRP is rich in bioactive growth factors such as platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), and transforming growth factor-beta (TGF-beta), which may enhance follicular activation, angiogenesis, and tissue repair when injected directly into the ovaries. Preliminary studies have reported improvements in ovarian reserve markers, including anti-Mullerian hormone (AMH) and antral follicle count (AFC), as well as encouraging trends in IVF outcomes following PRP treatment in women with POR and premature ovarian insufficiency. However, the current evidence is largely derived from small-scale, non-randomized studies, underscoring the need for rigorous clinical trials to validate its safety and efficacy.
References:
- Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L. ESHRE consensus on the definition of ’poor response’ to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi:10.1093/humrep/der092.
- Polyzos NP, Devroey P. A systematic review of randomized trials for the treatment of poor ovarian responders: is there any light at the end of the tunnel? Fertil Steril. 2011 Oct;96(4):1058-61.e7. doi:10.1016/j.fertnstert.2011.09.048.
- Herlihy NS, Seli E. The use of intraovarian injection of autologous platelet-rich plasma (PRP) in patients with poor ovarian response and premature ovarian insufficiency. Curr Opin Obstet Gynecol. 2022 Jun;34(3):133-137. doi:10.1097/GCO.0000000000000784.
- Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi:10.1007/s10815-021-02385-w.
- Cakiroglu Y, Yuceturk A, Karaosmanoglu O, Kopuk SY, Korun ZEU, Herlihy N, et al. Ovarian reserve parameters and IVF outcomes in 510 women with poor ovarian response (POR) treated with intraovarian injection of autologous platelet-rich plasma (PRP). Aging (Albany NY). 2022 Mar 22;14(6):2513-2523. doi:10.18632/aging.203972.
- Melo P, Navarro C, Jones C, Coward K, Coleman L. The use of autologous platelet-rich plasma (PRP) versus no intervention in women with low ovarian reserve undergoing fertility treatment: a non-randomized interventional study. J Assist Reprod Genet. 2020 Apr;37(4):855-863. doi:10.1007/s10815-020-01710-z.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •Expected Poor responders as defined by POSEIDON criteria (Groups 3-4).
排除标准
- •a) Severe endometriosis b) Known case of genetic aberrations c) BMI more than 30 d) Severe Male Factor Infertility.
结局指标
主要结局
AFC(antral follicle count), number of oocytes retrieved, M2 (mature)oocytes, Fertilization Rate, Blastocyst Formation Rate, and Clinical Pregnancy Rate.
时间窗: 1 to 3 months
次要结局
- Gonadotropin dosage, stimulation days, Pre-trigger E2, Miscarriage rate, Cycle Cancellation Trends, On-going pregnancy rate(From time of recruitment till three to four months)
研究者
DR Durga G Rao
OASIS Fertility hospital -unit of Sadguru healthcare services pvt.Ltd, HYDERABAD
