Identification of Biomarkers in Cervical Mucus (NCT06771401) | Clinical Trial Compass
RecruitingNot Applicable
Identification of Biomarkers in Cervical Mucus
Italy24 participantsStarted 2026-03-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterization by infrared spectroscopy of cervical mucus
Timeframe: 1 month (3 time points within a menstrual cycle)