Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anti-Müllerian Hormone Levels (AMH)
研究概览
简要总结
Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.
详细描述
Despite recent advances in reproductive medicine, poor ovarian response (POR) management is still considered to be very challenging. Commonly, POR patients present with reduced ovarian reserve and poor ovarian stimulation performance. The POR cycles are characterized by a very limited number of retrieved oocytes, subsequently leading to poor embryo formation and thus to high cycle cancelation rate. Despite the fact that POR constitutes a multifactorial condition, it is well demonstrated that advanced maternal age (AMA) is the most significant contributor of POR. As maternal age increases, reduction of neo-angiogenesis in ovaries is observed, leading to accelerated follicular loss. Considering that PRP contains several growth factors such as vascular endothelial growth factor (VEGF) and cytokines, it has been proposed that intraovarian infusion of autologous PRP could restore the ovarian niche microenvironment, increasing ovarian response to external gonadotropin stimulation. However, limited data are available with regards to PRP efficiency in POR patients, which are mainly originating from pilot or small cohort studies. This interventional non-randomised open-label study aims to investigate the effect of autologous PRP intraovarian infusion on improving POR patient performance by studying a large and well-controlled POR population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following):
- •Age ≥ 40 years
- •AMH < 1.1 ng/ml OR AFC < 7
- •≤ 3 oocytes with a conventional stimulation protocol
- •Discontinuation of any complementary/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.
- •Willing to comply with study requirements
排除标准
- •Any pathological disorder related to reproductive system anatomy
- •Cycle irregularities
- •Amenorrhea
- •Endometriosis
- •Adenomyosis
- •Fibroids and adhesions
- •Infections in reproductive system
- •Current or previous diagnosis of cancer in reproductive system
- •History of familiar cancer in reproductive system
- •Severe male factor infertility
- •Prior referral for Preimplantation Genetic Testing (PGT) -Ovarian inaccessibility -Endocrinological disorders (Hypothalamus-
- •Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
- •BMI>30 kg/m2 or BMI<18.5 kg/m2
- •Systematic autoimmune disorders
研究组 & 干预措施
Experimental: Group of participants receiving PRP treatment
Women presenting with POR, treated with autologous PRP intraovarian infusion during the mid-luteal phase, undergoing a subsequent stimulated fresh ET-ICSI cycle on the first month following PRP infusion
干预措施: Autologous platelet rich plasma (Biological)
结局指标
主要结局
Anti-Müllerian Hormone Levels (AMH)
时间窗: On day 2-3 of the first menstrual cycle post intervention
Serum anti-müllerian hormone (AMH) levels evaluated in the first menstrual cycle following intervention
Number of oocytes retrieved
时间窗: 34-36 hours following ovulation triggering
Number of oocytes retrieved following controlled ovarian stimulation in the first fresh ICSI-ET cycle performed on the first menstrual cycle following intervention
次要结局
- Clinical pregnancy rate(6-7 weeks following last menstruation)
- Antral Follicle Count (AFC)(On day 2-3 of the first menstrual cycle post intervention)