Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- LIVE BIRTH
研究概览
简要总结
Prospective cohort multicentric study including infertile patients undergoing a pregnancy test on βhCG day (around ET +11), after an ET in the context of an artificial cycle and receiving LPS with vaginal natural progesterone following the clinical practice in IVI RMA (Spain).
详细描述
The investigation team have already demonstrated that serum progesterone levels measured on the ET day in artificial cycles are related to pregnancy outcome. In this line, this problem can be countteracted after supplementation with an additional source of external progesterone, achieving similar ongoing pregnancy and live birth rates in women with serum progesterone levels below and above the threshold point determined on the ET day.
Despite this, it has been observed apparent differences on the maintenance of pregnancy in patients with a positive pregnancy test according to their serum progesterone levels measured on day ET+11, which is the same day in which we perform the pregnancy test. These differences seem to be originated due to later higher clinical miscarriage rates in patients with lower serum progesterone levels on day ET+11, despite their positive pregnancy test.
This fact may be due to patientes low serum progesterone levels, insufficient to maintain an ongoing pregnancy. Taking this into account, this study aim to confirm that serum progesterone levels on βhCG day are indeed related to final pregnancy outcome and to evaluate if there is any cut-off point of serum progesterone levels, as we have previously found on the ET day.
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 ≤ 35 kg/m2
- •Adequate endometrial thickness (>6.5mm) and pattern (Triple A structure) in the proliferative phase
排除标准
- •Uterine Pathology, adnexal pathology
- •Systemic diseases
结局指标
主要结局
LIVE BIRTH
时间窗: 1 YEAR
Record of live birth existence
POSITIVE PREGANCY
时间窗: 1 YEAR
Measurement of pregnancy test results
CLINICAL MISCARRIAGE
时间窗: 1 YEAR
Measurement of existence of Miscarriage after confirmation of at least one gestational sac on ultrasound
BIOCHEMICAL MISCARRIAGE
时间窗: 1 YEAR
Measurement of existence of miscarriage after a positive pregnancy test
ONGOING PREGNANCY
时间窗: 1 YEAR
Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound
次要结局
- SERUM P4 LEVEL ON B-HCG DAY(1 YEAR)
