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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05780489
Other study ID # 2211-VLC-158-EB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 14, 2023
Est. completion date December 2024

Study information

Verified date March 2024
Source Instituto Valenciano de Infertilidad, IVI VALENCIA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Determination of progesterone and oestradiol
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

Locations

Country Name City State
Spain Ivi Madrid Madrid
Spain IVI Valencia Valencia

Sponsors (2)

Lead Sponsor Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA MINT DIAGNOSTICS

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary E2 and P4 on Day 1 Measurement of saliva E2 adn P4 values on day 1 stimulation 1 YEAR
Primary E2 and P4 on Day 8 Measurement of saliva E2 adn P4 values on day 8 of stimulation 1 YEAR
Primary E2 and P4 on Triggering day Measurement of saliva E2 adn P4 values on triggering day 1 YEAR
Secondary BODY MASS INDEX Measurement of body mass index 1 year
Secondary DONOR'S AGE Age at the procedure moment 1 year
Secondary NUMBER OF OOCYTES Number of oocytes collected 1 YEAR
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