Exploratory Study on the Impact of Different Doses and Route of Administration of Exogenous Progesterone in Artificial Endometrial Preparation Cycles on Endometrial Structure and Function
概览
- 阶段
- 4 期
- 干预措施
- Progesterone
- 疾病 / 适应症
- Infertility, Female
- 发起方
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Endometrial gene expression profile
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
After so many years conducting artificial endometrial preparation cycles for embryo transfer, there is no clear indication about which is the optimal dose of exogenous progesterone in this scenario to optimize the outcome. Taking into account that the luteal phase can be controlled by measuring serum P levels (not done until now), the next step is to find out which is the best dose and route of administration of exogenous progesterone for luteal phase in artificial cycles.
Therefore, the aim of this experimental study is to compare the endometrial function and structure, as well as the serum P levels according to the use of different types of exogenous progesterone available on the market depending on their doses and route of administration (vaginal, subcutaneous or intramuscular). The endometrial receptivity status will be compared in the different artificial cycles with the one observed in a natural cycle, without exogenous progesterone (only the endogenous one) as a control group.
Endometrial receptivity will be analysed by means of endometrial function and structure, but not by pregnancy outcome as in this study an embryo cannot be replaced in the uterus because an endometrial biopsy needs to be done to do this type of research.
研究者
入排标准
入选标准
- •All women with no history of infertility who agree to participate in the study:
- •Age: 18-35 years old, both inclusive
- •Regular menstrual cycles
- •In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study.
排除标准
- •Subjects who meet one or more of the following will not be considered eligible to participate in the pilot study:
- •Simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study.
- •Taking oral contraceptives in the three months prior to signing informed consent.
- •Presence of uterine pathology (submucosal or intramural myomas \>4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx).
- •Background of thrombosis, breast cancer, systemic diseases.
- •Those unable to comprehend the investigational nature of the proposed study.
研究组 & 干预措施
I: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and vaginal natural micronized progesterone 400mg/12h
干预措施: Progesterone
II: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/24h
干预措施: Progesterone
III: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and subcutaneous natural progesterone 25mg/12h
干预措施: Progesterone
IV: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and a combination of subcutaneous natural progesterone 25mg/24h + vaginal natural micronized progesterone 400mg/24h
干预措施: Progesterone
V: Artificial endometrial preparation cycle
Artificial endometrial preparation cycle with estrogens and intramuscular natural progesterone 50mg/24h
干预措施: Progesterone
Natural menstrual cycle
Natural menstrual cycle (without any exogenous steroid hormone Treatment)
干预措施: Artificial Cycle (no intervention)
结局指标
主要结局
Endometrial gene expression profile
时间窗: 12 months
Determination of gene expression
次要结局
- Histological dating of endometrial biopsies(12 months)
- Progesterone concentration in the endometrium(12 months)
- Serum Progesterone concentrations(12 months)
- Correlation between progesterone levels in blood and uterus.(12 months)
- Correlation between serum and uterine levels with endometrial transcriptome and histological dating(12 months)