Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- The cumulative clinical pregnancy rate in half a year
研究概览
简要总结
A single-center, prospective, randomised controlled clinical trial (1:1 treatment ratio), designed to investigate the efficacy and safety of autologous SVF in improving the pregnancy outcome of infertile patients with POI.
详细描述
A single-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with POI based on the inclusion and exclusion criteria from Peking University Third Hospital. Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.The participation in this study will be approximately 2 years with a total of 6 visits and 3 follow-up phone calls.
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)
盲法说明
Due to the particularity of the treatment plan, the evaluator, namely the follow-up personnel who collect the postoperative medical history and the ultrasound evaluator, will be blinded in this trial to hide the grouping results. Blinding of participants and researchers is not possible.
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥20 and ≤39 years who have childbearing requirements.
- •Cessation of menstruation or oligomenorrhea for at least 4 months
- •Serum level of basal follicle stimulating hormone (FSH) >25 U/L at least 2 times (during the second to fourth day of the menstrual cycle or during amenorrhea; The interval between the two tests is 4 weeks)
- •Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml
- •Women with intact uterus and bilateral adnexa.
- •Voluntary participation and informed consent obtained.
排除标准
- •Women with autoimmune diseases.
- •Women with abnormal and uncontrolled thyroid function.
- •Women with tumors in bilateral adnexa that are not clearly benign or malignant.
- •Women with a history of malignant tumors, radiation therapy or chemotherapy.
- •Women with a history of venous thrombosis or pulmonary embolism during the screening period.
- •Women with severe illnesses that are not suitable for pregnancy, such as diseases of the circulatory system, urinary system, digestive system, endocrine system, respiratory system, immune system, mental or neurological system, etc.
- •Women who continuously used systemic glucocorticoids or other immunosuppressants for≥3 weeks within 6 months before administration and women who used systemic glucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressants within 3 days before administration.
- •Women who are allergic to the active ingredients or excipients of test drugs.
- •Women with a family history of severe genetic diseases or gynecologic malignancies.
结局指标
主要结局
The cumulative clinical pregnancy rate in half a year
时间窗: half a year after treatment
Percentage of patients with clinical pregnancy within half a year after treatment
次要结局
- Serum level of Anti-Mullerian hormone (AMH)(half a year after treatment)
- Antral follicles count (AFC)(half a year after treatment)
- Serum level of sex hormone (E2 and FSH)(half a year after treatment)
- Pregnancy outcome(2 years after treatment)
- Adverse reactions(2 years after treatment)
- Menstrual status(half a year after treatment)
- Ovarian volume(half a year after treatment)
- Health status of offspring(2 years after treatment)
研究者
Rui Yang
Clinical associate professor
Peking University Third Hospital