Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients

Conditions
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Infertility, Female, Reproductive Sterility

Intervention / Treatment
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* Diagnostic Test: Determination of progesterone and oestradiol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective unicentric study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing ovarian stimulation for IVF/ICSI<br>90 patients undergoing ovarian stimulation for IVF/ICSI; Low, average and high responders will be included in equal proportions, in order to cover the widest range of hormonal values (30 blood and saliva samples per ovarian stimulation point will be taken for determination of progesterone and oestradiol). | Diagnostic Test: Determination of progesterone and oestradiol<br>* Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.<br>|
| Experimental: Patients for embryo transfer (ET) undergoing hormonal replacement therapy<br>30 patients for embryo transfer (ET) undergoing hormonal replacement therapy. These patients will only have a progesterone determination in their blood and saliva samples on the day of ET. | Diagnostic Test: Determination of progesterone and oestradiol<br>* Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. | between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal variability of salivary progesterone and oestradiol levels | Measurement of progesterone and oestradiol levels | 12 months | 
| Patient User Experience with saliva collection | Registry of patient experience with saliva collection as users using a specific questionary. (Yes/No question) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ELISA, Saliva, Progesterone, Oestradiol, Early follicular phase, Mild follicular phase, Late follicular phase