Evaluation of Salivary ELISA for Hormone Monitoring in Donors

NCT05780489 — Not applicable, Unknown, 200 participants, Instituto Valenciano de Infertilidad, IVI VALENCIA

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RegistryNCT05780489, acronym MINT-II
StatusUnknown
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment200 (Estimated)
SponsorInstituto Valenciano de Infertilidad, IVI VALENCIA (Other); collaborators: MINT DIAGNOSTICS
ConditionsInfertility, Female, Reproductive Sterility
InterventionsDetermination of progesterone and oestradiol (Diagnostic test)
Datesstart 2023-04-14, primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2023-03-22, last updated 2024-03-12
Locations2 sites in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Infertility, Female All trials for Reproductive Sterility All trials of Determination of progesterone and oestradiol

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
DONORS UNDER CONTROLLED OVARIAN STIMULATIONExperimentalDiagnostic Test: Determination of progesterone and oestradiolSaliva samples will be analyzed using oestradiol and progesterone ELISA kits.
  • Determination of progesterone and oestradiol (Diagnostic test): Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

Sex: Female, ages: 18 Years to 35 Years

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.

+Locations (2)

FacilityCityCountryStatus
Ivi MadridMadridSpainRecruiting
IVI ValenciaValenciaSpainRecruiting