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4-step ASCOT in POI Women to Promote Follicular Rescue

NCT04475744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-02-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

    collaborator OTHER

  • IVI Madrid

    collaborator OTHER

  • Hospital Universitario La Fe

    collaborator OTHER

  • Fundación IVI

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475744 on ClinicalTrials.gov