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临床试验/NCT05750849
NCT05750849招募中不适用

Impact of Serum Progesterone Levels on the Day of β-hCG Test in Artificial Cycles on the Ongoing Pregnancy Rate.

Instituto Valenciano de Infertilidad, IVI VALENCIA1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2023年1月25日最近更新:
适应症

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

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)

研究者

发起方
Instituto Valenciano de Infertilidad, IVI VALENCIA
申办方类型
Other
责任方
Sponsor

研究点 (1)

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