Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
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
- Diurnal variability of salivary progesterone and oestradiol levels(12 months)
- Patient User Experience with saliva collection(12 months)