Identification of Diagnostic, Prognostic and Predictive Biomarkers in Cervical Mucus for Reproductive and Gynecological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Characterization by infrared spectroscopy of cervical mucus
研究概览
简要总结
Cervical mucus is a biological fluid secreted by the endocervical glandular epithelium whose quantitative and qualitative characteristics vary in response to the hormonal stimulus produced by the ovary during the woman's menstrual cycle. As a fertility factor, it performs numerous biological functions: transport, nourishment, defense and capacitation of spermatozoa, defense against pathogens of the female genital tract.
The aim of this research will be to deepen the knowledge of the biochemical characteristics of cervical mucus, in particular to perform characterization by infrared spectroscopy, for the identification of diagnostic, prognostic and predictive biomarkers for disorders affecting the female reproductive system.
A healthy control population and a cohort of patients affected by unexplained infertility will be enrolled for the longitudinal study of the menstrual cycle with ultrasound and hormonal monitoring and serial sampling of cervical mucus.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HEALTHY CONTROL
- •Women of 18-45 years old,
- •Use of the Billings Ovulation Method® for at least three months in the last three years
- •Proven fertility
- •STUDY COHORT
- •Women of 18-45 years old,
- •Women affected by unexplained infertility
排除标准
- •Virgo women
- •Women incapable of understanding and wanting
- •Women who have had sexual intercourse in the two days prior to cervical mucus sampling
- •Pregnancy, exclusive breastfeeding
- •Amenorrhea
- •Gynecological hormone ongoing therapies or suspended for less than three months
- •Cervico -vaginal infections
- •Psychiatric pathologies
- •Untreated/decompensated endocrine-metabolic disorders
- •Coagulopathies and renal pathologies under dialysis treatment
- •Refusal of informed consent
- •Previous, current or suspected oncological pathology
研究组 & 干预措施
CERVICAL MUCUS ANALYSIS
Analysis of the characterization by infrared spectroscopy of cervical mucus and its variations during the different phases of the menstrual cycle in cases vs healthy controls groups
干预措施: cervical mucus sampling (Diagnostic Test)
结局指标
主要结局
Characterization by infrared spectroscopy of cervical mucus
时间窗: 1 month (3 time points within a menstrual cycle)
Analysis of the spectra as revealed using by infrared spectroscopy on samples of cervical mucus. Analysis of their variations during the different phases of the menstrual cycle in cases group vs healthy controls groups.
次要结局
未报告次要终点
研究者
SCAMBIA GIOVANNI
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS