NCT04475744

4-step ASCOT in POI Women to Promote Follicular Rescue

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fundación IVI · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Ovarian Insufficiency

Interventions

Type	Name	Description
DRUG	G-CSF treatment for Bone marrow derived stem cell Mobilization	Mobilization treatment. On the fifth day, collection will be started.
PROCEDURE	Platelet Rich Plasma ovarian injection	Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.

Timeline

• Start date: 2021-03-05
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2020-07-17
• Last updated: 2024-02-28

Locations

2 sites across 1 country: Spain