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4-step ASCOT in POI Women to Promote Follicular Rescue

Primary Purpose

Premature Ovarian Insufficiency

Status
Active
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
G-CSF treatment for Bone marrow derived stem cell Mobilization
Platelet Rich Plasma ovarian injection
Sponsored by
Fundación IVI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ovarian Insufficiency

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IVI Madrid
  • IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

4-step ASCOT arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

FSH, AMH and E2 levels
hormone levels in plasma
Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.
COS and IVF cycle variables will be recorded if COS initiated
Menses recovery (YES/NO)
If menses recovery is noted by patients should be informed and recorded
Ovarian function (YES/NO)
Antral follicles detected by untrasound, menses recover and decrease in FSH levels will be considered as positive ovarian function

Full Information

First Posted
July 10, 2020
Last Updated
January 24, 2023
Sponsor
Fundación IVI
Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid, Hospital Universitario La Fe
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1. Study Identification

Unique Protocol Identification Number
NCT04475744
Brief Title
4-step ASCOT in POI Women to Promote Follicular Rescue
Official Title
4-step ASCOT in POI Women to Promote Follicular Rescue
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación IVI
Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid, Hospital Universitario La Fe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ovarian Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
4-step ASCOT arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
G-CSF treatment for Bone marrow derived stem cell Mobilization
Intervention Description
Mobilization treatment. On the fifth day, collection will be started.
Intervention Type
Procedure
Intervention Name(s)
Platelet Rich Plasma ovarian injection
Intervention Description
Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.
Primary Outcome Measure Information:
Title
AFC
Description
Follicular development assessed by antral follicular count between controls and treated patients after the 4-step ASCOT technique during the follow up period.
Time Frame
6-month
Secondary Outcome Measure Information:
Title
FSH, AMH and E2 levels
Description
hormone levels in plasma
Time Frame
6-month
Title
Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.
Description
COS and IVF cycle variables will be recorded if COS initiated
Time Frame
6-month
Title
Menses recovery (YES/NO)
Description
If menses recovery is noted by patients should be informed and recorded
Time Frame
6-12 months
Title
Ovarian function (YES/NO)
Description
Antral follicles detected by untrasound, menses recover and decrease in FSH levels will be considered as positive ovarian function
Time Frame
6-12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
IVI Madrid
City
Madrid
Country
Spain
Facility Name
IVI Valencia
City
Valencia
Country
Spain

12. IPD Sharing Statement

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4-step ASCOT in POI Women to Promote Follicular Rescue

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