Evaluation of Salivary ELISA for Hormone Monitoring in Donors

NCT05780489 | Recruiting

• 1 other identifier: 2211-VLC-158-EB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility, Female; Reproductive Sterility

Keywords

SALIVA; DONNORS; OESTRADIOL; PROGESTERONE

Outcome Measures

Primary Outcomes (3)

• E2 and P4 on Day 1

  Measurement of saliva E2 adn P4 values on day 1 stimulation

  1 YEAR

• E2 and P4 on Day 8

  Measurement of saliva E2 adn P4 values on day 8 of stimulation

  1 YEAR

• E2 and P4 on Triggering day

  Measurement of saliva E2 adn P4 values on triggering day

  1 YEAR

Secondary Outcomes (3)

• BODY MASS INDEX

  1 year

• DONOR'S AGE

  1 year

• NUMBER OF OOCYTES

  1 YEAR

Study Arms (1)

DONORS UNDER CONTROLLED OVARIAN STIMULATION

EXPERIMENTAL

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

Diagnostic Test: Determination of progesterone and oestradiol

Interventions

Determination of progesterone and oestradiol DIAGNOSTIC_TEST

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

DONORS UNDER CONTROLLED OVARIAN STIMULATION

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Simultaneous participation in other clinical study, that at the investigator's criteria could interfere with the results of this study.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead
• MINT DIAGNOSTICS: collaborator

Study Sites (2)

Ivi Madrid

Madrid, 28023, Spain

RECRUITING

IVI Valencia

Valencia, 46015, Spain

RECRUITING

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective multicentric study,

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 22, 2023
• Study Start: April 14, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)