4-step ASCOT in POI Women to Promote Follicular Rescue

Premature Ovarian Insufficiency Clinical Trial

Official title: 4-step ASCOT in POI Women to Promote Follicular Rescue

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Menopause, Premature
• Premature Ovarian Insufficiency
• Primary Ovarian Insufficiency

• NCT number: NCT04475744
• Study type: Interventional
• Source: Fundación IVI
• Status: Completed
• Phase: Phase 3
• Start date: March 5, 2021
• Completion date: October 30, 2023