Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Restoration of menstrual cycle
研究概览
简要总结
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
详细描述
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in POI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age < 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels >25 IU/L recorded on two occasions >4 weeks apart
- •Normal Karyotype: 46, XX
- •Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, 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
- •AMH > 8 pmol/L
- •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 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
Participants receiving PRP treatment
Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion
干预措施: Autologous Platelet Rich Plasma (Biological)
Participants receiving Platelet Free Plasma (PFP) treatment
Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion
干预措施: Placebo-Platelet Free Plasma (Biological)
结局指标
主要结局
Restoration of menstrual cycle
时间窗: Three months
Regular menstrual cycle
Serum FSH levels
时间窗: Follow-up period of three months entailing monthly evaluation
Serum FSH levels evaluated monthly for three consecutive months
次要结局
- Serum AMH levels(Follow-up period of three months entailing monthly evaluation)
- Serum LH levels(Follow-up period of three months entailing monthly evaluation)
- Serum Estradiol levels(Follow-up period of three months entailing monthly evaluation)
- Serum Progesteron levels(Follow-up period of three months entailing monthly evaluation)
- Antral Follicle Count (AFC)(Follow-up period of three months entailing monthly evaluation)