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

March 11, 2024 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Collaborators

MINT DIAGNOSTICS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2211-VLC-158-EB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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