Identification of Biomarkers in Cervical Mucus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
cervical mucus sampling
Diagnostic testMonitoring of menstrual cycle will be conducted in the follicular, ovulatory and luteal phases during which cervical mucus, serum and urine samples will be collected and pelvic ultrasound scans performed (3-5 ultrasound scans/samples within the cycle).
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: CERVICAL MUCUS ANALYSISOther 1 intervention
Trial outcomes
Primary outcomes
1
Characterization by infrared spectroscopy of cervical mucus
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.
Time frame
1 month (3 time points within a menstrual cycle)Sponsors and contacts
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Source ClinicalTrials.gov