| Registry | NCT05780489, acronym MINT-II |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 200 (Estimated) |
| 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 2023-04-14, primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2023-03-22, last updated 2024-03-12 |
| Locations | 2 sites 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 donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles.
Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative.
The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DONORS UNDER CONTROLLED OVARIAN STIMULATION | Experimental | Diagnostic Test: Determination of progesterone and oestradiol | Saliva samples will be analyzed using oestradiol and progesterone ELISA kits. |
Sex: Female, ages: 18 Years to 35 Years
Inclusion criteria * Informed consent form dated and signed * Woman undergoing COS for oocyte donation * Age 18-35, inclusive * Regular menstrual cycles * In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study Exclusion criteria • Simultaneous participation in other clinical study, that at the investigator's criteria could interfere with the results of this study.
| Facility | City | Country | Status |
|---|---|---|---|
| Ivi Madrid | Madrid | Spain | Recruiting |
| IVI Valencia | Valencia | Spain | Recruiting |