A Pilot Study of the Effect of RECO-18 Containing Natural Plant Extracts on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Ongoing pregnancy rate at 12 weeks' gestation
研究概览
简要总结
How to improve the fertility of infertile women has become a hot topic in the field of assisted reproduction. Animal experiment has shown that RECO-18 significantly improved the female fertility in mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Therefore the investigators aim to conduct a pilot study to explore the effect of RECO-18 in infertile women undergoing assisted reproduction treatment. This study is a prospective, randomized, controlled clinical study. The treatment group takes RECO-18 while the control group takes the multi-vitamins. The primary indicator is the ongoing pregnancy rate at 12 weeks' gestation; the secondary indicators are the number of oocytes retrieved, the normal fertilization rate and the rate of high quality embryos, implantation rate, clinical pregnancy rate, and early miscarriage rate.
详细描述
Mitochondrial function is closely related to oocyte quality in female. Deficiency of multiple micronutrients is common in infertile women, and supplementation with multiple micronutrients has antioxidant effects to reduce the damage of oxidative stress to fertility, and helps to improve the outcomes of assisted reproductive treatment. RECO-18 is a functional food containing a variety of plant extracts and enzymatic soy phospholipids. In in vivo and in vitro senescent models, the investigators found RECO-18 to improve oocyte quality mainly by regulating the mitochondrial apoptosis pathway. The investigators also found RECO-18 significantly improved the fertility of mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Based on the animal experiments, the investigators intend to conduct a clinical trial to explore whether RECO-18 plays a role in improving oocyte and embryo quality and pregnancy outcomes in infertile women undergoing in vitro fertilization-embryo transfer.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female, 20 to 40 years old
- •the 1st or 2nd cycle of IVF/ICSI treatment
- •BMI≤30Kg/m2
- •with bilateral ovaries
- •be eligible for IVF/ICSI treatment
排除标准
- •Repeated implantation failures (with previous 3 or more IVF/ICSI failures)
- •moderate to severe endometriosis
- •untreated hydrosalpinx
- •untreated endometrial disease
- •contraindications for assisted reproductive techniques or gestation
- •a history of ovarian surgery
- •expected poor ovarian response (POR) or previous POR
- •polycystic ovarian syndrome
- •participants in clinical trials of other drugs within one month prior to enrollment; • hypersensitivity to follicle-stimulating hormone α, FSH, human menopausal gonadotropin, LH or excipients
- •uncontrolled endocrine diseases (such as hyperthyroidism, hypothyroidism, adrenal gland disease, obesity, etc.)
- •percutaneous epididymal sperm aspiration or testicular sperm aspiration
结局指标
主要结局
Ongoing pregnancy rate at 12 weeks' gestation
时间窗: At 12 weeks' gestation
Gestational sac with embryocardia-beat detected on ultrasound at 12 weeks' gestation
次要结局
- Number of retrieved oocytes(Two weeks after oocyte retrieval)