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临床试验/NCT05987657
NCT05987657已完成不适用

Comparison of Two Methods to Assess Progesterone Concentration in Patient During IVF Protocol on Triggering Day: Salivary Versus Blood Test

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Reliability of salivary dosage of progesterone compared to blood sample.

研究概览

简要总结

Nowadays, 1/7 couple consult because of infertility and some of them will need in vitro fertilization +/- intracytoplasmic sperm injection (IVF+/- ICSI). The IVF process includes a 14 days stimulation with FSH +/- LH in an agonist or antagonist protocol. The monitoring consists of regular ultrasound scan and blood sample. During the stimulation protocol many test have been proposed to predict the success of IVF. However, progesterone dosage on triggering day seems to be the only relevant exam. Indeed, when the progesterone blood concentration is low, the pregnancy rate is decreased. The only way to obtain progesterone concentration is a blood sample. The IVF journey is known to be stressful with many injections. Therefore, the salivary dosage appear to be more patient friendly. This kind of dosage has already been studied yet never use in routine because of a lack of repeatability. The laboratory of Lyon has developed a new technique to overcome this issue by using a liquid chromatography-mass spectrometry.

The aim of this work is as a first step to assess the repeatability, reliability and precision of salivary dosage on triggering day for IVF patient compared to blood concentration of progesterone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Adult patients between 18 and under 43 years old
  • •in the course of IVF more or less ICSI of the PMA service of the HFME with transfer of fresh embryo
  • •Signature of an express consent
  • •Understanding the French language, both oral and written.
  • •Affiliated to a social security scheme

排除标准

  • •Persons deprived of their liberty by a judicial or administrative decision
  • •Persons subject to psychiatric care
  • •Persons admitted to a health or social establishment for purposes other than research
  • •Participants in another study that could impact the results of the present study, in particular those related to the level of progesterone.
  • •Adults subject to a legal protection measure (guardianship, curatorship)

研究组 & 干预措施

Salivary and blood progesterone dosage

Other

IVF patients with fresh embryo transfer having a dosage of progesterone, salivary and blood, on triggering day

干预措施: Salivary and blood progesterone dosage (Diagnostic Test)

结局指标

主要结局

Reliability of salivary dosage of progesterone compared to blood sample.

时间窗: At the inclusion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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