Impact of Serum Progesterone Concentration on the Day of Embryo Transfer in Modified Natural Cycles and Stimulated Cycles on Ongoing Pregnancy Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
Prospective cohort unicentric study including infertile patients undergoing an embryo transfer in the context of natural or stimulated cycles and receiving luteal phase support with vaginal natural progesterone following the clinical practice in our clinic in IVIRMA Valencia, Spain.
详细描述
Progesterone as a promoter of endometrial maturation is essential for the process of embryo implantation. The transformation of the endometrium from a proliferative state to a receptive state depends on the adequate progesterone exposure of the endometrium. Therefore, in any assisted reproduction technique (ART) the management of the luteal phase with exogenous administered progesterone, aiming to achieve a receptive endometrial state, is an essential part of the therapy. This important part of infertility-treatment is called luteal phase support (LPS).
Currently, there is a scientific debate and research regarding the timing, the dose and route of administration of exogenous progesterone in ART cycles. For years, the administration of progesterone was based on a "one fits all"- concept, mainly driven from the doctors and patients' preference regarding dose, timing and route of administration of the exogenous progesterone. Due to the lack of solid and evidence-based knowledge, the LPS improving investigating LPS is of outmost importance.
Therefore, improving the LPS is continuously in the focus of research and investigation. Main objectives of those efforts are to clarify the optimal timing, dosage and route of administration of progesterone for every possible ART procedure, in order to improve therapy outcomes. Of special interest in this wide field is the management of LPS in embryo-transfer-cycles such as substituted cycles and modified natural cycles for frozen-thawed cycles, and in fresh embryo-transfers after stimulated cycles.
Measuring serum progesterone levels in the luteal phase of a transfer cycle seems to be a promising approach in resolving the former mentioned doubts. Now, research focuses on luteal-phase serum progesterone levels as a predictor of outcomes. The discovery of certain thresholds of progesterone levels in the serum would give us a handy tool for individualizing the LPS with the main objective to improve outcomes.
Previous studies could show that there exist certain thresholds of serum progesterone in substituted cycles that could be used as a predictor. Furthermore, the same group could show that modifying the dose and the route of administration in the sense of individualizing LPS can improve outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The subject must provide written informed consent prior to any study related procedures
- •Women ≤50 years old
- •BMI ≤ 40 kg/m2
- •Adequate endometrial thickness (>6.5mm) and pattern (Triple A structure) in the proliferative phase
- •Regular menstrual cycles
排除标准
- •Uterine Pathology, adnexal pathology
- •Systemic diseases
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 12 months
Presence or absence of ongoing pregnancy
次要结局
- Live Birth(12 months)
- Implantation rate(12 months)
- Pregnancy Loss(12 months)
