Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

In donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Ivi Madrid
RECRUITING
Madrid
IVI Valencia
RECRUITING
Valencia
Time Frame
Start Date: 2023-04-14
Estimated Completion Date: 2024-12
Participants
Target number of participants: 200
Treatments
Experimental: DONORS UNDER CONTROLLED OVARIAN STIMULATION
Saliva samples will be analyzed using oestradiol and progesterone ELISA kits.
Related Therapeutic Areas
Sponsors
Collaborators: MINT DIAGNOSTICS
Leads: Instituto Valenciano de Infertilidad, IVI VALENCIA

This content was sourced from clinicaltrials.gov