MINT-II: Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05780489

Collaborator

MINT DIAGNOSTICS (Other)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Reproductive Sterility	Diagnostic Test: Determination of progesterone and oestradiol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a prospective multicentric study,This is a prospective multicentric study,

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Salivary ELISA for Hormone Monitoring in Donors

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: DONORS UNDER CONTROLLED OVARIAN STIMULATION

Saliva samples will be analyzed using oestradiol and progesterone ELISA kits.

Diagnostic Test: Determination of progesterone and oestradiol

Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.