Premature Ovarian InsufficiencyPhase 3NCT04475744
4-step ASCOT in POI Women to Promote Follicular Rescue
A Phase 3 study testing G-CSF treatment for Bone marrow derived stem cell Mobilization and Platelet Rich Plasma ovarian injection in people with Premature Ovarian Insufficiency, run by Fundación IVI at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- G-CSF treatment for Bone marrow derived stem cell Mobilization and Platelet Rich Plasma ovarian injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesSpain
- Study dates
- 5 Mar 2021to 30 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- G-CSF treatment for Bone marrow derived stem cell Mobilization, Platelet Rich Plasma ovarian injection
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF treatment for Bone marrow derived stem cell MobilizationDrug
Mobilization treatment. On the fifth day, collection will be started.
Platelet Rich Plasma ovarian injectionProcedure or surgery
Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: G-CSF treatment for Bone marrow derived stem cell Mobilization; Procedure: Platelet Rich Plasma ovarian injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AFC
Follicular development assessed by antral follicular count between controls and treated patients after the 4-step ASCOT technique during the follow up period.
Measured: 6-month
Secondary outcomes (4)
FSH, AMH and E2 levels
hormone levels in plasma
Measured: 6-month
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
Measured: 6-month
Menses recovery (YES/NO)
If menses recovery is noted by patients should be informed and recorded
Measured: 6-12 months
Ovarian function (YES/NO)
Antral follicles detected by untrasound, menses recover and decrease in FSH levels will be considered as positive ovarian function
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start5 Mar 2021
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación IVI
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid, Hospital Universitario La Fe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475744
- Sponsor's protocol ID
- 1912-FIVI-113-SH
- Status last verified
- Sep 2023
- First submitted
- 10 Jul 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-step ASCOT in POI Women to Promote Follicular Rescue
- ClinicalTrials.gov ID
- NCT04475744
- Acronym / sponsor ID
- 1912-FIVI-113-SH
- Conditions
- Premature Ovarian Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fundación IVIUniversity, hospital or other
- Collaborators
- Instituto Valenciano de Infertilidad, IVI VALENCIA, IVI Madrid, Hospital Universitario La Fe
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: G-CSF treatment for Bone marrow derived stem cell Mobilization, Procedure: Platelet Rich Plasma ovarian injectionPOI 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. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects who meet the following will be considered eligible to participate in the clinical trial:
Key exclusion criteria (10 listed)
- Subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSF treatment for Bone marrow derived stem cell MobilizationMobilization treatment. On the fifth day, collection will be started. | Drug | 4-step ASCOT arm |
| Platelet Rich Plasma ovarian injectionMobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed. | Procedure or surgery | 4-step ASCOT arm |
Primary outcome
AFC
Time frame: 6-month
Follicular development assessed by antral follicular count between controls and treated patients after the 4-step ASCOT technique during the follow up period.
4 secondary outcomes
FSH, AMH and E2 levels
Time frame: 6-month
Number of COS and IVF cycle parameters for each patient, initiated before and after treatment.
Time frame: 6-month
Menses recovery (YES/NO)
Time frame: 6-12 months
Ovarian function (YES/NO)
Time frame: 6-12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing G-CSF treatment for Bone marrow derived stem cell Mobilization and Platelet Rich Plasma ovarian injection in people with Premature Ovarian Insufficiency, run by Fundación IVI at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AFC (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.