4-step ASCOT in POI Women to Promote Follicular Rescue
Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
To promote follicular development in POI women, G-CSF mobilized activated platelet rich
plasma will be directly injected into the ovarian medulla.
This is a prospective, observational, multicentric, open, pilot-controlled randomized trial
which seeks to evaluate the impact of the 4-step ASCOT technique on the ovarian reserve and
reproductive outcomes of POI patients. The study will be developed in two phases.
In a first step, POI women will randomized to control or undergo the 4-step ASCOT technique
based on the direct ovarian injection of G-CSF mobilized and activated PRP. Follow up (AFC,
AMH, FSH and E2 determinations) will be developed for 3 month in the controls and for 6
months in the treated and COS initiated if growing antral follicles detected. In the second
phase, POI women allocated to control group after completed the follow up period will undergo
the 4-step ASCOT technique, as described in the previous phase but only one ovary will be
injected, then they will undergo a 6-month follow up period as described above.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación IVI
Collaborators:
Hospital Universitario La Fe Instituto Valenciano de Infertilidad, IVI VALENCIA IVI Madrid