Ignite Creation Date:
2024-05-06 @ 2:57 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04475744
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2020-07-10
Brief Title:
4-step ASCOT in POI Women to Promote Follicular Rescue
Sponsor:
Fundación IVI
Organization:
Fundación IVI
Study Overview
Official Title:
4-step ASCOT in POI Women to Promote Follicular Rescue
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None