Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure (POF)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pregnancy
研究概览
简要总结
Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established in 10 cases.
ESS cut off point for menstruation and pregnancy was 6.
详细描述
Out of 112 high risk patients for POF, diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by immubohistchemical (IH) staining by stem cell marker OCT4. IH expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Score (ESS).
After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).
These cases were of ESS 5 and 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menarche female less than 40 years old.
- •Normal karyotyping female.
- •Primary ovarian failure females
- •Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
- •Agree to sign the designed consent for the study.
排除标准
- •Autoimmune diseases.
- •Breast cancer, ovarian cancer.
- •Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
- •Those with major medical problems such as malignancy, hepatitis, etc.
结局指标
主要结局
Pregnancy
时间窗: 104 weeks
Hormonal analysis
次要结局
- Menstruation(104 weeks)
研究者
Edessy Mahmoud
Professor
Al-Azhar University