In Vitro Maturation (IVM) of Human Oocytes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pregnancy
研究概览
简要总结
We hypothesize that the combination of natural cycle IVF or low dose gonadotropin injection combined with In Vitro Maturation (IVM) (Natural IVF/IVM) is a viable option for a selected population of infertility patients who cannot tolerate exogenous gonadotropins or are at risk of ovarian hyperstimulation syndrome.
详细描述
Natural IVF/IVM may be an attractive treatment alternative to conventional controlled ovarian hyperstimulation (COH)/IVF treatment for infertile women in particular for a select group.
Natural IVF/IVM offers several advantages over conventional COH protocols for IVF including:
- Elimination of the need for gonadotropin ovarian stimulation
- Elimination of risk of developing OHSS
- Simplification of treatment, eliminating the need for frequent blood tests and ultrasound monitoring
- Reduced cost of treatment
- Avoiding potential side effects of gonadotropins, including weight gain, bloating, breast tenderness, nausea, mood swings
- Eliminates concerns about the potential risk of malignancy that may be associated with multiple cycles of ovarian stimulation in a predisposed population.
This pilot study will be conducted to assess the clinical efficacy of natural IVF/IVM
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
- 25 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Each subject must be female.
- •Each subject must have an indication for COH and IVF or ICSI.
- •Each subject must be willing and able to provide written informed consent for the trial.
- •Each subject must be ≤42 years of age at the time of signing informed consent.
- •Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to signing informed consent must be available.
排除标准
- •Subject with premature ovarian failure.
- •Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction.
- •Subject with malformation or absence of uterus.
- •Subject tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).
- •Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone.
结局指标
主要结局
Pregnancy
时间窗: 1 month
Establishment of a successful pregnancy
Implantation
时间窗: 1 month
fetal hearts per embryo replaced
live birth rates
时间窗: 9 months
次要结局
- Endocrine parameters (FSH, LH, estradiol [E2], progesterone [P], anti-Mullerian hormone [AMH])(2 weeks)
- Number and quality of embryos generated(1 week)
- Endometrial thickness(2 weeks)
- Number of fertilized oocytes(2 days)
- Fertilization rate(1 day)
- Multiple pregnancy and miscarriage rates(9 months)
- Number and size distribution of follicles (≥11 mm, ≥15 mm, and ≥17 mm) as documented by ultrasonography during treatment(2 weeks)
- Number and quality of oocytes retrieved(1 day)
- Oocyte maturation rate(1 week)
- Neonatal outcomes(9 months)