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

Primary Purpose

Infertility, Female, Reproductive Sterility

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Determination of progesterone and oestradiol
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility, Female focused on measuring SALIVA, DONNORS, OESTRADIOL, PROGESTERONE

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ivi MadridRecruiting
  • IVI ValenciaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DONORS UNDER CONTROLLED OVARIAN STIMULATION

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

BODY MASS INDEX
Measurement of body mass index
DONOR'S AGE
Age at the procedure moment
NUMBER OF OOCYTES
Number of oocytes collected

Full Information

First Posted
February 28, 2023
Last Updated
May 16, 2023
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborators
MINT DIAGNOSTICS
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1. Study Identification

Unique Protocol Identification Number
NCT05780489
Brief Title
Evaluation of Salivary ELISA for Hormone Monitoring in Donors
Acronym
MINT-II
Official Title
Evaluation of Salivary ELISA for Hormone Monitoring in Donors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborators
MINT DIAGNOSTICS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Reproductive Sterility
Keywords
SALIVA, DONNORS, OESTRADIOL, PROGESTERONE

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective multicentric study,
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DONORS UNDER CONTROLLED OVARIAN STIMULATION
Arm Type
Experimental
Arm Description
Saliva samples will be analyzed using oestradiol and progesterone ELISA kits.
Intervention Type
Diagnostic Test
Intervention Name(s)
Determination of progesterone and oestradiol
Intervention Description
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
Primary Outcome Measure Information:
Title
E2 and P4 on Day 1
Description
Measurement of saliva E2 adn P4 values on day 1 stimulation
Time Frame
1 YEAR
Title
E2 and P4 on Day 8
Description
Measurement of saliva E2 adn P4 values on day 8 of stimulation
Time Frame
1 YEAR
Title
E2 and P4 on Triggering day
Description
Measurement of saliva E2 adn P4 values on triggering day
Time Frame
1 YEAR
Secondary Outcome Measure Information:
Title
BODY MASS INDEX
Description
Measurement of body mass index
Time Frame
1 year
Title
DONOR'S AGE
Description
Age at the procedure moment
Time Frame
1 year
Title
NUMBER OF OOCYTES
Description
Number of oocytes collected
Time Frame
1 YEAR

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ivi Madrid
City
Madrid
ZIP/Postal Code
28023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MONICA TORIBIO
Phone
+34 651 79 10 00
Email
IVESMADRID@IVIRMA.COM
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesto Bosch, MDPhD
Phone
963050900
Email
ernesto.bosch@ivirma.com
First Name & Middle Initial & Last Name & Degree
Laura Caracena, Mrs
Phone
963050925
Email
laura.caracena@ivirma.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Salivary ELISA for Hormone Monitoring in Donors

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