Outcome of Pregnancy in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived-Mesenchymal Stromal Cells
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Spontaneous pregnancy rate
研究概览
简要总结
In this controlled trial, poor ovarian responder women will be treated with transplantation of autologous menstrual blood stem cells. The investigators will attempt to assess the safety and efficacy of this procedure for the treatment of infertility in POR patients compared to control group.
详细描述
With economic development, procreation delays have resulted in more women seeking medical help for infertility treatment. Because the quality and quantity of oocytes are affected by physiological age, despite advances in assisted reproductive technology (ART), managing infertility in women with poor ovarian response (POR) remains a daily challenge for physicians.
Adult mesenchymal stromal cell (MSC) therapy has gained particular interest in recent years because it may provide a supportive microenvironment for oocyte development from quiescent primordial follicles. Human MSC transplantation has been shown in preclinical studies to host ovaries and restore their function and structure premature ovarian failure (POF) animal models.
Because of their encouraging characteristics such as ease of access, high availability, monthly repeatability of sampling, less ethical considerations, lack of tumor-causing potential, protected property, and significant trans-differentiation capacity, endometrial-derived stromal cells have been considered in a wide range of studies since 2007. Menstrual blood-derived stromal cells (MenSCs), on the other hand, are derived from endometrial tissue and can be collected in a non-invasive manner, making them especially useful in the treatment of reproductive disorders. The investigators attempted to assess the safety and efficacy of intraovarian injection of MenSCs for the treatment of infertility in POR patients based on this evidence.
The results of this clinical trial's phases I and II indicated that Men-MSCs could be considered as a potential treatment to restore the fertility capability of POR women. Based on these findings, the investigators have designed a Phase III controlled trial of autologous MenSC therapy for patients with POR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Serum AMH < 0.1 ng/ml (at the screening visit and in the absence of OC or sex-steroid intake)
- •Antral follicular count (AFC) in both ovaries < 4 (at screening visit and in the absence of OC or sex-steroid intake)
- •Positive history of at least1 standard previous IVF-ET or ICSI-ET
- •Normal thyroid hormones (TSH and FT4)
- •Normal level of prolactin,
- •Normal level of fasting blood sugar
- •Normal Liver tests (SGOT, SGPT)
- •Normal level of BUN, creatinine
- •Negative Infectious tests (HIV, HCV, HBS Ag, VDRL)
- •Normal coagulation factors (PT, PTT, BT, CT)
- •Normal serum levels of sodium, potassium, calcium, phosphorus
- •Negative history of endometrioma or other ovarian cysts
- •Negative history of previous ovarian surgery
- •Negative history of cancer
- •Negative history of a known autoimmune disorder.
排除标准
- •Positive history of hydrosalpinx or anatomical uterine disorders (In vaginal sonography or HSG)
- •Severe male factors of their husbands (count <15 million/ml)
结局指标
主要结局
Spontaneous pregnancy rate
时间窗: 3 months after stem cell injection
Number of participants that establish a spontaneous clinical pregnancy after stem cell injection
Pregnancy rate after ICSI
时间窗: 4 weeks after embryo transfer
Number of participants that establish a clinical pregnancy after embryo transfer
次要结局
- Number of high quality embryos number(Day 3-5 after follicle puncture)
- Biochemical pregnancy rate(12-16 days after oocyte pick-up)
- Number of MII oocytes(Day 0 after follicle puncture)
- Hormone levels(2 and 4 months after stem cell injection)
- Live birth rate(at a follow-up time of 30 days after delivery)
- Number of oocytes(Day 0 after follicle puncture)
- Clinical pregnancy rate(4 weeks after embryo transfer)
- Number of embryos(Day 3-5 after follicle puncture)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](at a follow-up time after 1 year)