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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- - Gene expression for the whole transcriptome (22000 genes) related to progesterone treatments response in the window of implantation. - Number of differential expressed genes between P treatment groups in comparison with its natural cycle
研究概览
简要总结
To compare the endometrial function (endometrial gene expression) 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).
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women with no history of infertility who agree to participate in the study:
- •Informed consent form (ICF) dated and signed.
- •Age: 18-35 years old , both inclusive
- •Regular menstrual cycles (between 22 and 35 days)
- •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: 1.Simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study. 2.Taking contraceptives in the three months prior to signing informed consent. 3.Presence of uterine pathology (submucosal or intramural myomas >4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx). 4.Background of thrombosis, breast cancer, systemic diseases. 5.Those unable to comprehend the investigational nature of the proposed study.
结局指标
主要结局
- Gene expression for the whole transcriptome (22000 genes) related to progesterone treatments response in the window of implantation. - Number of differential expressed genes between P treatment groups in comparison with its natural cycle
- Gene expression for the whole transcriptome (22000 genes) related to progesterone treatments response in the window of implantation. - Number of differential expressed genes between P treatment groups in comparison with its natural cycle
次要结局
未报告次要终点
研究者
Elena Labarta
Scientific
Ivi Valencia S.L.