A Randomized Controlled Study on Autologous Platelet-rich Plasma Injection in Patients With Poor Ovarian Response
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 主要终点
- Number of retrieved oocytes
研究概览
简要总结
Poor ovarian response (POR) is a pathological condition where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a low number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a small number of retrieved oocytes, and a low clinical pregnancy rate. Premature ovarian insufficiency (POI) is a special type of this condition and is one of the most difficult infertility diseases to treat. The incidence of POR and POI in reproductive-aged women in China is increasing year by year, making them key and challenging issues in reproductive medicine. Novel local ovarian cell therapy can improve the microenvironment for follicle development, promote the development and ovulation of "dormant" primordial follicles, and improve the quality of oocytes. This study intends to conduct a prospective randomized controlled trial to evaluate the safety and efficacy of autologous platelet-rich plasma (PRP) local injection therapy for improving ovarian reserve and IVF-ET outcomes in patients with POR and POI. This study is expected to improve the fertility of POR patients from the perspective of autologous cell therapy. The autologous PRP local injection technique does not involve ethical barriers, is easy to standardize the diagnosis and treatment process and operation system, and is suitable for clinical translation and promotion.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have fertility requirements and are seeking IVF treatment at the Reproductive Medicine Center of Peking University Third Hospital
- •Age ≤ 45 years old, infertility duration ≥ 1 year
- •Meeting the diagnostic criteria for POI or the Poseidon diagnostic criteria for POR
- •Previous controlled ovarian stimulation resulted in no more than 3 oocytes retrieved and/or no transplantable embryos and/or previous embryo implantation failure ≥ 2 times
- •Uterus and bilateral adnexa are intact
- •BMI 18.5 - 29 kg/m²
- •Participants must have given informed consent for this study and voluntarily signed a written informed consent form.
排除标准
- •Congenital abnormalities of reproductive organs
- •Septicemia, platelet dysfunction syndrome and severe thrombocytopenia and other coagulation disorders or other hematological diseases
- •Suffering from autoimmune diseases or other endocrine disorders, with abnormal thyroid function and uncontrolled condition
- •Having a mass in the adnexal area with an unclear benign or malignant nature
- •Complicated with severe cardiovascular and cerebrovascular diseases, malignant tumors, hematological diseases and mental disorders, patients with impaired function of important organs
- •Those who have used systemic corticosteroids within the last 2 weeks, or used antiplatelet drugs such as aspirin within the last 48 hours
- •In the acute inflammatory stage
- •Those with a history of venous thrombosis or pulmonary embolism during the screening period
结局指标
主要结局
Number of retrieved oocytes
时间窗: 6 months
The treatment is considered successful if the number of retrieved oocytes increases by ≥ 2 after the treatment. The effective rate of treatment = (number of effective treatment cycles) / (total number of cycles) × 100%
次要结局
- Blood anti-Müllerian hormone (AMH) level(6 months)
- Number of antral follicles(6 months)
- clinical pregnancy rate(1 year)
研究者
Ma Caihong
Chief Physician
Peking University Third Hospital