4-step ASCOT in POI Women to Promote Follicular Rescue

NCT ID: NCT04475744

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2023-10-30

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.

Conditions

Premature Ovarian Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control arm

POI women radomized to control arm will undergo a 3-month follow up for: AFC, AMH, FSH and E2 determinations.COS will be 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

4-step ASCOT arm

POI women randomized to the 4-step ASCOT technique will receive a direct ovarian injection of G-CSF mobilized and activated PRP. For each patient, both ovaries will be directly injected with the G-CFS activated PRP (4-step ASCOT). Follow up (AFC, AMH, FSH and E2 determinations) will be developed for 6 months and COS initiated if growing antral follicles detected.

Group Type: EXPERIMENTAL

G-CSF treatment for Bone marrow derived stem cell Mobilization

Intervention Type: DRUG

Mobilization treatment. On the fifth day, collection will be started.

Platelet Rich Plasma ovarian injection

Intervention Type: PROCEDURE

Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.

Interventions

G-CSF treatment for Bone marrow derived stem cell Mobilization

Mobilization treatment. On the fifth day, collection will be started.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects who meet the following will be considered eligible to participate in the clinical trial:

1. Informed consent form dated and signed.

2. Age between 18 and 38 (both inclusive)

3. Women who meet the ESHRE criteria for POI [41]

• presence of menstrual disturbance defined as oligo/amenorrhea for at least 4 months
• biochemical confirmation as evidenced by an elevated FSH level >25IU/L on two occasions > 4 weeks apart
• Or fluctuating POI when one of the above criteria is missing.

Exclusion Criteria

• Subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial:

1. Simultaneous participation in another clinical study that, at the researcher's criteria, could interfere with the results of this study.

2. Age ≥ 39

3. Autoimmune origin of POI

4. Genetic risk factors for POR (e.g. Turner Syndrome, FMR1 premutation, etc);

5. Acquired conditions associated with POR (e.g. Chemotherapy);

6. Clinical endometriosis

7. Previous ovarian surgery considered as a risk of POR

8. Previous gonadotoxic treatment

9. Known intolerance or allergic reactions to components of the study product, i.e. lactose

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: collaborator

IVI Madrid

OTHER

Sponsor Role: collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role: collaborator

Fundación IVI

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IVI Madrid

Madrid, , Spain

IVI Valencia

Valencia, , Spain

Countries

Spain

Other Identifiers

1912-FIVI-113-SH

Identifier Type: -

Identifier Source: org_study_id