Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women
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 hormonal profile of women in menopause.
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 menopausal women. 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 menopausal women.
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
- 45 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 45-55 years old
- •Amenorrhea for at least 12 months
- •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
- •Previous POI diagnosis
- •Abnormal karyotype
- •Endometriosis
- •Adenomyosis
- •Fibroids and adhesions
- •Infections in reproductive system
- •Current or previous diagnosis of reproductive system cancer
- •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
Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.
干预措施: Autologous PRP intra ovarian infusion (Biological)
Control Group: Participants receiving Platelet Free Plasma
Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.
干预措施: Autologous PFP intra ovarian infusion (Biological)
结局指标
主要结局
Restoration of menstrual cycle
时间窗: Three months
Menstrual cycle restoration
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 progesterone levels(Follow-up period of three months entailing monthly evaluation)
- Serum estradiol levels(Follow-up period of three months entailing monthly evaluation)
- Serum AMH levels(Follow-up period of three months entailing monthly evaluation)
- Serum LH levels(Follow-up period of three months entailing monthly evaluation)
- Antral Follicle Count(Follow-up period of three months entailing monthly evaluation)