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

I

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Enrolling

Conditions

Reproductive Sterility
Infertility, Female

Treatments

Diagnostic Test: Determination of progesterone and oestradiol

Study type

Interventional

Funder types

Other

Identifiers

NCT05780489
2211-VLC-158-EB

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

DONORS UNDER CONTROLLED OVARIAN STIMULATION
Experimental group
Description:
Saliva samples will be analyzed using oestradiol and progesterone ELISA kits.
Treatment:
Diagnostic Test: Determination of progesterone and oestradiol

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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