SALIVA_MINT: Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Patients undergoing ovarian stimulation for IVF/ICSI 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
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
|
Experimental: Patients for embryo transfer (ET) undergoing hormonal replacement therapy 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
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
|
Outcome Measures
Primary Outcome Measures
- To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. [12 months]
between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations
Secondary Outcome Measures
- Diurnal variability of salivary progesterone and oestradiol levels [12 months]
Measurement of progesterone and oestradiol levels
- Patient User Experience with saliva collection [12 months]
Registry of patient experience with saliva collection as users using a specific questionary. (Yes/No question)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | IVI Valencia | Valencia | Spain | 46003 |
Sponsors and Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- MINT DIAGNOSTICS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2107-VLC-071-EB