4-step ASCOT in POI Women to Promote Follicular Rescue

NCT04475744 | Completed Phase 3

• 1 other identifier: 1912-FIVI-113-SH
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• AFC

  Follicular development assessed by antral follicular count between controls and treated patients after the 4-step ASCOT technique during the follow up period.

  6-month

Secondary Outcomes (4)

• FSH, AMH and E2 levels

  6-month

• Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.

  6-month

• Menses recovery (YES/NO)

  6-12 months

• Ovarian function (YES/NO)

  6-12 months

Study Arms (2)

Control arm

NO INTERVENTION

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.

4-step ASCOT arm

EXPERIMENTAL

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.

Drug: G-CSF treatment for Bone marrow derived stem cell Mobilization; Procedure: Platelet Rich Plasma ovarian injection

Interventions

G-CSF treatment for Bone marrow derived stem cell Mobilization DRUG

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

4-step ASCOT arm

Platelet Rich Plasma ovarian injection 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.

4-step ASCOT arm

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who meet the following will be considered eligible to participate in the clinical trial:
• Informed consent form dated and signed.
• Age between 18 and 38 (both inclusive)
• 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.

You may not qualify if:

• Subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial:
• Simultaneous participation in another clinical study that, at the researcher's criteria, could interfere with the results of this study.
• Age ≥ 39
• Autoimmune origin of POI
• Genetic risk factors for POR (e.g. Turner Syndrome, FMR1 premutation, etc);
• Acquired conditions associated with POR (e.g. Chemotherapy);
• Clinical endometriosis
• Previous ovarian surgery considered as a risk of POR
• Previous gonadotoxic treatment
• Known intolerance or allergic reactions to components of the study product, i.e. lactose

Sponsors & Collaborators

• Fundación IVI: lead
• Instituto Valenciano de Infertilidad, IVI VALENCIA: collaborator
• IVI Madrid: collaborator
• Hospital Universitario La Fe: collaborator

Study Sites (2)

IVI Madrid

Madrid, Spain

Location

IVI Valencia

Valencia, Spain

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 17, 2020
• Study Start: March 5, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-09

Locations

ES (2)