Infertility, Female, Reproductive Sterility
Conditions
Keywords
SALIVA, DONNORS, OESTRADIOL, PROGESTERONE
Brief 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.
Interventions
DIAGNOSTIC_TESTDetermination of progesterone and oestradiol
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
Sponsors
MINT DIAGNOSTICS
Instituto Valenciano de Infertilidad, IVI VALENCIA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a prospective multicentric study,
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E2 and P4 on Day 1 | 1 YEAR | Measurement of saliva E2 adn P4 values on day 1 stimulation |
| E2 and P4 on Day 8 | 1 YEAR | Measurement of saliva E2 adn P4 values on day 8 of stimulation |
| E2 and P4 on Triggering day | 1 YEAR | Measurement of saliva E2 adn P4 values on triggering day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BODY MASS INDEX | 1 year | Measurement of body mass index |
| DONOR'S AGE | 1 year | Age at the procedure moment |
| NUMBER OF OOCYTES | 1 YEAR | Number of oocytes collected |
Countries
Spain
Outcome results
None listed