Identifying biomarkers in cervical mucus
Official title: Identification of Diagnostic, Prognostic and Predictive Biomarkers in Cervical Mucus for Reproductive and Gynecological Disorders
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06771401 · Data updated 2026-11-12
This project will test whether infrared spectroscopy of cervical mucus can find biomarkers that distinguish women with unexplained infertility from healthy, fertile women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 24 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Roma) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | October 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | March 25, 2026 |
| Trial ID | NCT06771401 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–45 who are either proven fertile (with recent use of the Billings Ovulation Method®) or women diagnosed with unexplained infertility, who are not pregnant or breastfeeding and have no active gynecologic infection or recent hormonal therapy.
✕Probably not a fit
Patients unlikely to benefit include those outside the 18–45 age range, women with known causes of infertility, current pregnancy or exclusive breastfeeding, ongoing or recently stopped hormonal therapies, active cervico-vaginal infections, virgins (due to sampling), or serious uncontrolled medical conditions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will enroll two groups of women—proven fertile controls and women with unexplained infertility—and follow them across menstrual cycles. Participants will undergo ultrasound and hormone monitoring while providing serial cervical mucus samples. Samples will be analyzed by infrared spectroscopy to characterize biochemical patterns and search for diagnostic, prognostic, or predictive markers. Results from the two groups will be compared to identify spectral features linked to reproductive dysfunction.
Why it matters
Potential benefit: If successful, this could enable a simple, noninvasive mucus-based test to help diagnose or predict fertility problems and better target treatments.
How similar studies have gone: Cervical mucus composition has been studied previously, but applying infrared spectroscopy to identify clinical biomarkers for infertility is largely exploratory and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Ostetricia e Patologia Ostetrica
Rome, Roma, Italy Recruiting
Study contacts
- Principal investigator: Tullio Ghi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Tullio Ghi
- Email: tullio.ghi@policlinicogemelli.it
- Phone: +390630155701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.