Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
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
- Number of oocytes retrieved
研究概览
简要总结
Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).
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 fresh ET-ICSI cycles' performance in regard to patients presenting with POR. 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 POR 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
- 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, 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
- •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 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
Control Group: participants receiving Platelet Free Plasma
Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period
干预措施: Placebo (Biological)
Group of participants receiving PRP treatment
Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period.
干预措施: PRP (Biological)
结局指标
主要结局
Number of oocytes retrieved
时间窗: 34-36 hours following hCG administration
Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period
AMH levels
时间窗: Follow-up period of three months entailing monthly evaluation
Serum AMH levels evaluated monthly for three consecutive months
次要结局
- Antral Follicle Count(Follow-up period of three months entailing monthly evaluation)
- Clinical pregnancy rate(6-7 weeks following last menstruation)