| Registry | NCT05184777, acronym SALIVA_MINT |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 120 (Actual) |
| Sponsor | Instituto Valenciano de Infertilidad, IVI VALENCIA (Other); collaborators: MINT DIAGNOSTICS |
| Conditions | Infertility, Female, Reproductive Sterility |
| Interventions | Determination of progesterone and oestradiol (Diagnostic test) |
| Dates | start 2022-02-03, primary completion 2022-05-17, completion 2023-02-20, first posted 2022-01-11, last updated 2023-03-01 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Infertility, Female All trials for Reproductive Sterility All trials of Determination of progesterone and oestradiol
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients undergoing ovarian stimulation for IVF/ICSI | Experimental | Diagnostic Test: Determination of progesterone and oestradiol | 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). |
| Patients for embryo transfer (ET) undergoing hormonal replacement therapy | Experimental | Diagnostic Test: Determination of progesterone and oestradiol | 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. |
Sex: Female, ages: 18 Years to 45 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| IVI Valencia | Valencia | Spain |