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临床试验/NCT07282288
NCT07282288尚未招募不适用

A Randomized Controlled Study on Autologous Cell Injection Into the Ovaries of Patients With Poor Ovarian Response

Peking University Third Hospital0 个研究点目标入组 198 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
198
主要终点
Number of retrieved oocytes

研究概览

简要总结

Poor ovarian response (POR) is a pathological state where the ovaries do not respond well to the stimulation of gonadotropins. It is mainly characterized by a small number of developing follicles, a high cancellation rate of the ovarian stimulation cycle, a low 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. New 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 autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy for patients with POR and POI, and conduct a prospective exploratory study to evaluate the safety of this clinical technique. Subsequently, a prospective randomized controlled trial will be conducted to evaluate the safety and efficacy of autologous fat vascular matrix components (SVF) or autologous platelet-rich plasma (PRP) local injection therapy in improving ovarian reserve and IVF-ET outcomes. This study is expected to improve the fertility of patients with POR from the perspective of autologous cell therapy. The autologous SVF and PRP local injection techniques do not involve ethical barriers, are easy to standardize the diagnosis and treatment process and operation system, and are 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

入选标准

  • Women who have fertility requirements and are seeking IVF treatment
  • 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 22 - 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: 6month

次要结局

  • anti-Müllerian hormone level(6 month)
  • Number of antral follicles(6 month)
  • clinical pregnancy rate(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ma Caihong

Chief Physician

Peking University Third Hospital

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