Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal 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
- Serum FSH levels
研究概览
简要总结
Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.
详细描述
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal 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 improving ovarian tissue functionality in perimenopausal 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
- 40 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels.
- •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
- •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 PGT
- •Ovarian inaccessibility
- •Previous POI diagnosis -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
Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.
干预措施: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion (Biological)
结局指标
主要结局
Serum FSH levels
时间窗: Follow-up period of three months entailing monthly evaluation
Serum FSH levels evaluated monthly for three consecutive months.
Restoration of menstrual cycle regularity
时间窗: Three months
Regular Menstrual cycle
次要结局
- Serum AMH 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)
- Serum LH levels(Follow-up period of three months entailing monthly evaluation)
- Antral Follicle Count(Follow-up period of three months entailing monthly evaluation)