Progesterone Levels and Frozen Embryo Transfer Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 659
- 主要终点
- Ongoing pregnancy
研究概览
简要总结
Frozen embryo transfers (FET) now represent the majority of all embryo transfer cycles, and upwards of 60% live births in United States are now attributable to frozen embryo transfers (1). Exogenous progesterone for endometrial decidualization and luteal phase support is thought to be critical to both optimizing endometrial receptivity for implantation as well as sustaining early pregnancy prior to reliable secretory activity of the early placenta.
The purpose of this study is to:
- Determine the prevalence of low serum progesterone levels (less than 10 ng/ml) among patients undergoing a programmed embryo transfer cycle on the day of frozen embryo transfer.
- Determine if serum progesterone < 10 ng/ml on the day of frozen embryo transfer is associated with poorer FET outcomes: ongoing pregnancy (primary outcome), live birth, biochemical pregnancy, and clinical pregnancy.
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
- 否
入选标准
- •Signed informed consent
- •Female patient undergoing programmed frozen embryo transfer using exogenous estrogen and progesterone, with exogenous progesterone administered via a combination of vaginal progesterone (Endometrin®) (2-3 times daily) and intermittent progesterone-in-oil (PIO) (every 3rd day) according to standard protocol. Protocols involving other formulations of vaginal progesterone (e.g. Crinone®, Prometrium®, will also be included).
- •Planned transfer one 1 euploid embryo. Recruited patients will have at least 1 euploid embryo available for transfer.
- •Standard eligibility criteria to undergo frozen embryo transfer at Shady Grove Fertility.
- •18 years and older
排除标准
- •Age less than 18 years or greater than 51 years
- •Planned intervention based on serum progesterone concentration measured any time after initiation of intramuscular or vaginal progesterone.
- •Uterine cavity abnormality that has not been surgically corrected.
- •Any medical or surgical contraindication to undergoing programmed frozen embryo transfer or pregnancy.
- •Planned use of embryos cryopreserved by slow-freeze, prior to blastocyst stage, or other than PGT-A normal.
- •Currently breast feeding, pregnancy, or having a contraindication to pregnancy.
- •Participation in any experimental drug study within 60 days prior to screening.
结局指标
主要结局
Ongoing pregnancy
时间窗: Through study completion, an average of 1 year
At the completion of the study, a chart review will be performed to determine which patients who participated in this study have an ongoing pregnancy. This information is recorded in our electronic medical record as a binary variable (ongoing pregnancy - yes or no).
次要结局
未报告次要终点