Influence of Local Biopsy of the Endometrium Prior to Controlled Ovarian Stimulation for IVF or ICSI Procedure on the Rates of Embryo Implantation, Clinical Pregnancy and Live Birth in ART
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 6
- 主要终点
- Rate of clinical pregnancy
研究概览
简要总结
In vitro fertilization (IVF) is the only available solution for many couples with various forms of infertility. The embryo implantation step in the IVF procedure is a complex multistage process and represents the majority of the causes of the IVF failure. Several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. However, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of IVF patients improves the rates of embryo implantation, clinical pregnancy and live birth.
详细描述
They are possible mechanisms by which endometrial sampling may increase receptivity and improve clinical pregnancy rate of IVF-ET. First, local injury to proliferative phase endometrium might induce the decidualization of the endometrium, and increase its implantation rate. Second, local injury to the endometrium might provoke the wound healing, involving a mass secretion of different cytokines and growth factor, which are beneficial for embryo implantation. Last, the injury might make the endometrium maturation.
This study proposes to evaluate the efficiency of an endometrial injury in the first controlled ovarian hyperstimulation cycle on the rate of clinical pregnancy, in assisted reproductive technologies. This study will compare 2 groups of patients. The first group will undergo biopsy of the endometrium before the IVF; the second will undergo the IVF alone. Inclusions will be conducted on 33 months; the patients will be in the study for a period of 36 weeks. The total duration of the study is 39 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary or secondary infertility
- •first or second IVF attempt
- •aged ≥18 and ≤38 years
- •regular menstrual cycles
- •FSH≤ 12IU/L
- •Informed consent signed
排除标准
- •ovocyte donor
- •pathology of the uterus or annexes
- •Body mass index (BMI)> 35
- •ongoing vaginal infection
- •undetermined vaginal bleeding
- •contraindication to the Cornier pipette or to these treatments : Gonal F®, Puregon®, Ovitrelle®, Utrogestan®,
- •women included in another study on medically assisted procreation
- •any administrative or legal supervision
结局指标
主要结局
Rate of clinical pregnancy
时间窗: 5 weeks after the embryo implantation in an IVF procedure
次要结局
- Adverse effects during the local injury (biopsy) to the endometrium(during the biopsy)
- Rate of miscarriage/extra-uterine pregnancy/multiple pregnancy(first trimester after the IVF)
- Evaluation of the patients pain intensity and type from the biopsy.(during and after the biopsy)
- Rate of embryo implantation(5 weeks after the embryo implantation)
- Rate of clinical pregnancy(3 months after the IVF implantation)