Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Conditions
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Infertility, Female, Reproductive Sterility

Intervention / Treatment
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* Diagnostic Test: Determination of progesterone and oestradiol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective multicentric study,
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DONORS UNDER CONTROLLED OVARIAN STIMULATION<br>Saliva samples will be analyzed using oestradiol and progesterone ELISA kits. | Diagnostic Test: Determination of progesterone and oestradiol<br>* Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E2 and P4 on Day 1 | Measurement of saliva E2 adn P4 values on day 1 stimulation | 1 YEAR | 
| E2 and P4 on Day 8 | Measurement of saliva E2 adn P4 values on day 8 of stimulation | 1 YEAR | 
| E2 and P4 on Triggering day | Measurement of saliva E2 adn P4 values on triggering day | 1 YEAR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BODY MASS INDEX | Measurement of body mass index | 1 year | 
| DONOR'S AGE | Age at the procedure moment | 1 year | 
| NUMBER OF OOCYTES | Number of oocytes collected | 1 YEAR | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SALIVA, DONNORS, OESTRADIOL, PROGESTERONE