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OpenTrials
Completed

NCT Number: NCT05184777

Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVI Valencia

Valencia, 46003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Determination of progesterone and oestradiol

Diagnostic Test

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

Primary outcomes

  1. To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.

    Time frame: 12 months

    between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations

Secondary outcomes

  1. Diurnal variability of salivary progesterone and oestradiol levels

    Time frame: 12 months

    Measurement of progesterone and oestradiol levels

  2. Patient User Experience with saliva collection

    Time frame: 12 months

    Registry of patient experience with saliva collection as users using a specific questionary. (Yes/No question)

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Collaborators

  • MINT DIAGNOSTICS

Registry information

Acronym: SALIVA_MINT

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2022
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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