Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Not Applicable

Recruiting

• Conditions: Infertility, Female; Reproductive Sterility
• Interventions: Diagnostic Test: Determination of progesterone and oestradiol

• Registration Number: NCT05780489
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Study Start: 2023-04-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DONORS UNDER CONTROLLED OVARIAN STIMULATION	Determination of progesterone and oestradiol	Saliva samples will be analyzed using oestradiol and progesterone ELISA kits.

Primary Outcome Measures

Name	Time	Method
E2 and P4 on Day 1	1 YEAR	Measurement of saliva E2 adn P4 values on day 1 stimulation
E2 and P4 on Triggering day	1 YEAR	Measurement of saliva E2 adn P4 values on triggering day
E2 and P4 on Day 8	1 YEAR	Measurement of saliva E2 adn P4 values on day 8 of stimulation

Secondary Outcome Measures

Name	Time	Method
NUMBER OF OOCYTES	1 YEAR	Number of oocytes collected
BODY MASS INDEX	1 year	Measurement of body mass index
DONOR'S AGE	1 year	Age at the procedure moment

Trial Locations

Locations (2)

Ivi Madrid; 🇪🇸 Madrid, Spain

IVI Valencia; 🇪🇸 Valencia, Spain