Efficacy and Safety of Shen Que (RN8) Moxibustion on Reproductive Outcomes in Women of Advanced Reproductive Age (≥35 Years Old) With Unexpected Ovarian Poor Ovarian Response Undergoing in Vitro Fertilization and Embryo Transfer (IVF-ET): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
Moxibustion of Shen Que (RN8) can increase the number of embryos available for transfer, thus improving pregnancy outcomes in women of advanced reproductive age who experience unexpected poor ovarian response.
详细描述
According to the traditional Chinese medicine (TCM) theory, Shen Que (RN8) is the place where the vitality converges under the navel, and is closely connected with the vitality generated by the kidney Qi. Therefore, stimulating Shen Que may stimulate the essence stored in the kidney, and improve the fertility of "五七" (≥ 35 years old) women.
Shen Que moxibustion has been shown to improve ovarian functional reserve in patients with ovarian insufficiency in previous studies. Nevertheless, studies on Shen Que moxibustion in advanced women with unexpected poor ovarian response (POR) who undergo IVF-ET are very limited. Consequently, we designed this randomized controlled trial to validate the hypothesis that Shen Que moxibustion improves reproductive outcomes in unexpected POR women.
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
- None
入排标准
- 年龄范围
- 35 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •≥35 years old with normal pre-stimulation ovarian reserve parameters (antral follicle count (AFC) ≥ 5 or anti-mullerian hormone (AMH) ≥1.2 ng/ml) and with an expected poor ovarian response (fewer than 4 oocytes) after standard ovarian stimulation.
排除标准
- •Individuals with a Body Mass Index (BMI) ≥ 35 Kg/m2
- •Those using the natural cycle or mild stimulation for IVF/intracytoplasmic sperm injection (ICSI) treatment
- •Those with a history of unilateral oophorectomy or recurrent pregnancy loss, defined as two or more spontaneous abortions
- •Acceptors of donated oocytes or performed either In vitro Maturation (IVM) or blastocyst biopsy for Preimplantation Genetic Diagnosis (PGD) or Preimplantation Genetic Testing for Aneuploidies (PGT-A)
- •Those previously diagnosed with congenital (e.g., mediastinal uterus and double uterus) or acquired (e.g., submucosal myoma and adenomyosis) uterine abnormalities
- •Patients with extremely advanced age ( ≥ 45 years old)
- •Presence of a non-surgically treated hydrosalpinx or endometrial polyp and an ovarian endometriosis cyst requiring surgery, during ovarian stimulation
结局指标
主要结局
Number of oocytes retrieved
时间窗: One month
Number of oocytes retrieved
次要结局
- Cumulative Clinical pregnancy rate(Fourteen months)
- Cumulative live birth rate(Eighteen months)
- Cycle cancellation rate(One month)
- Implantation rate(Fourteen months)
- Good quality embryo rate(One month)
- Number of Metaphase II (MII) eggs(One month)
研究者
Jing-Yan Song
Clinical Professor
Shandong University of Traditional Chinese Medicine