Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Infertility, Female Clinical Trial

— MINT-II  

Official title:

Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780489
• Other study ID #: 2211-VLC-158-EB
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Reproductive Sterility

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