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Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05184777
Acronym
SALIVA_MINT
Enrollment
120
Registered
2022-01-11
Start date
2022-02-03
Completion date
2023-02-20
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female, Reproductive Sterility

Keywords

ELISA, Saliva, Progesterone, Oestradiol, Early follicular phase, Mild follicular phase, Late follicular phase

Brief summary

In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.

Interventions

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

Sponsors

MINT DIAGNOSTICS
CollaboratorUNKNOWN
Instituto Valenciano de Infertilidad, IVI VALENCIA
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Prospective unicentric study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing IVF/ICSI treatment * Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy * Aged from18-45 years old. * BMI 19-30 kg/m2 * Signed written informed consent

Exclusion criteria

• Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.12 monthsbetween salivary ELISA assays and serum determination of progesterone and oestradiol concentrations

Secondary

MeasureTime frameDescription
Diurnal variability of salivary progesterone and oestradiol levels12 monthsMeasurement of progesterone and oestradiol levels
Patient User Experience with saliva collection12 monthsRegistry of patient experience with saliva collection as users using a specific questionary. (Yes/No question)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026