Monitoring hormone levels in donors using saliva
Evaluation of Salivary ELISA for Hormone Monitoring in Donors
This study is testing if measuring hormone levels in saliva can help women donating eggs feel more comfortable by replacing blood tests while still tracking their hormone changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA Academic / other |
| Locations | 2 sites (Madrid and 1 other locations) |
| Trial ID | NCT05780489 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of salivary ELISA to monitor hormone levels, specifically oestradiol and progesterone, in women undergoing controlled ovarian stimulation for oocyte donation. The goal is to establish a correlation between hormone concentrations in saliva and the size of developing follicles, which is traditionally monitored through blood draws. By utilizing saliva, the study aims to provide a less invasive and more comfortable alternative for patients, potentially reducing the physical and emotional burden associated with frequent blood sampling.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy women aged 18-35 who are undergoing controlled ovarian stimulation for oocyte donation.
Not a fit: Patients who are not undergoing assisted reproduction treatments or those with medical conditions that could interfere with hormone levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the comfort and convenience of hormone monitoring for patients undergoing assisted reproduction treatments.
How similar studies have performed: While the use of saliva for hormone monitoring is a novel approach, similar studies have shown promise in other areas of diagnostics, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Informed consent form dated and signed * Woman undergoing COS for oocyte donation * Age 18-35, inclusive * Regular menstrual cycles * In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study Exclusion criteria • Simultaneous participation in other clinical study, that at the investigator's criteria could interfere with the results of this study.
Where this trial is running
Madrid and 1 other locations
- Ivi Madrid — Madrid, Spain (Recruiting)
- IVI Valencia — Valencia, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.