Actively Recruiting
Identification of Biomarkers in Cervical Mucus
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-03-25
24
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Identification of Biomarkers in Cervical Mucus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- Use of the Billings Ovulation Method® for at least three months in the last three years (healthy control group)
- Proven fertility (healthy control group)
- Women aged 18 to 45 years (study cohort)
- Women affected by unexplained infertility (study cohort)
You will not qualify if you...
- Virgin women
- Women unable to understand or unwilling to participate
- Women who had sexual intercourse in the two days prior to cervical mucus sampling
- Pregnancy or exclusive breastfeeding
- Amenorrhea
- Current gynecological hormone therapies or therapies stopped less than three months ago
- Cervico-vaginal infections
- Psychiatric disorders
- Untreated or uncontrolled endocrine-metabolic disorders
- Blood clotting disorders and kidney diseases requiring dialysis
- Refusal to give informed consent
- Previous, current, or suspected cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
Rome, Roma, Italy, 00168
Actively Recruiting
Research Team
T
Tullio Ghi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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