Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer: a Population Pharmacokinetic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Average plasma progesterone concentration.
研究概览
简要总结
During an In Vitro Fertilization (IVF) attempt, several embryos are obtained but not all of them can be transferred to the uterus in the same cycle due to the risk of multiple pregnancies. Thus, it is very common for these couples to benefit from cryopreservation. Patients scheduled for frozen embryo transfer (TEC) receive estrogen and progesterone replacement therapy to prepare the endometrium for implantation. Data from the literature recently showed that low progesterone on the day of embryo transfer was responsible for a significantly higher rate of implantation failure and miscarriage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patient undergoing a frozen embryo transfer in an artificial cycle at the AMP center of the Toulouse University Hospital.
- •Affiliation to a social security scheme or equivalent
- •Patient fulfilling the conditions for access to the AMP according to French bioethics law
- •Patient having given her consent (oral or written) after clear and fair information
排除标准
- •Patient who received intramuscular administration of progesterone during the endometrial preparation phase.
- •Patient with comprehension difficulties.
- •Protected adult patient (safeguard of justice, guardianship or curatorship)
研究组 & 干预措施
Patients having embryo transfert
Patients benefit from the usual treatment for frozen embryo transfer with a preparatory cycle of the artificial endometrium: 150 µg of percutaneous estradiol for approximately 11 days and 200 mg of progesterone morning and evening to be taken vaginally for 2 days in case of embryo transfer at day 2 stage, 3 days in case of embryo transfer at day 3 stage, 5 days in case of day 5 embryo transfer or 6 days in case of day 6 embryo transfer.
干预措施: Questionnaire (Other)
结局指标
主要结局
Average plasma progesterone concentration.
时间窗: Day of embryo transfer.
Dosage of apparent clearance (CL/F)
次要结局
未报告次要终点