Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Follicular development rate
研究概览
简要总结
This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.
详细描述
According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells (test group). Group B was the hormone replacement group (control group).
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, Care Provider, Investigator)
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
- •Those who meet the POF diagnostic criteria and have no spontaneous follicular activity;
- •Married, 20 years old ≤ age < 40 years old;
- •The average diameter of each ovary is > 10 mm;
- •Have agreed to sign the informed consent form.
排除标准
- •Female and/or male chromosomal abnormalities;
- •Endometriosis, adenomyosis;
- •Postoperative ovarian borderline or malignant tumor;
- •Uterine dysplasia;
- •Associated with female autoimmune disease or other serious internal surgical diseases;
- •hormone replacement contraindications;
- •In the past 1 year, had received an experimental study of premature ovarian failure in the external hospital;
- •Male azoospermia or severe oligozoospermia.
研究组 & 干预措施
UC-MSCs+hormone replacement group
Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).
干预措施: transplantation of human UC-MSCs into ovaries of POI patients (Procedure)
UC-MSCs+hormone replacement group
Group A was the hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells group(test group).
干预措施: hormone replacement treatment (Drug)
hormone replacement group
Group B was the hormone replacement group (control group).
干预措施: hormone replacement treatment (Drug)
结局指标
主要结局
Follicular development rate
时间窗: 9-12 months
Follicular development and hormonal examination were performed 1 week before treatment and at 1, 2, and 3 weeks after treatment to evaluate the development of follicles. If there is no follicular development in the third week, stop the drug after 1 week, and contact the next treatment time after menstruation. During the follow-up period to half a year after the end of the last treatment, the follicular development activity rate was observed.
次要结局
- Changes in blood flow index in the ovary(9-12 months)
- Clinical pregnancy rate(9-12 months)
研究者
Li-jun Ding
principal investigator
Nanjing University