Cervical Mucus Dysfunction, Infertility, Female
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTcervical mucus sampling
Monitoring 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).
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization by infrared spectroscopy of cervical mucus | 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. |
Countries
Italy
Contacts
CONTACTTullio Ghi
PRINCIPAL_INVESTIGATORTullio Ghi
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Outcome results
None listed