A Phase 3 interventional study of G-CSF treatment for Bone marrow derived stem cell Mobilization and Platelet Rich Plasma ovarian injection in Premature Ovarian Insufficiency, sponsored by Fundación IVI. Completed at 2 sites in Spain. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Fundación IVI · Phase 3, Interventional, and Treatment
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.
128 studies on the registry are indexed under Menopause, Premature; 23 are open to participants now.
This study's enrollment of 42 is below the median of 47 across 80 interventional studies indexed under Menopause, Premature.
Browse Menopause, Premature studies →Fundación IVI is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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Subjects who meet the following will be considered eligible to participate in the clinical trial:
Women who meet the ESHRE criteria for POI [41]
Exclusion Criteria:
Subjects who meet one or more of the following will not be considered eligible to participate in the clinical trial:
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.
Drug: G-CSF treatment for Bone marrow derived stem cell Mobilization · Procedure: Platelet Rich Plasma ovarian injection
Mobilization treatment. On the fifth day, collection will be started.
Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.
AFC
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
FSH, AMH and E2 levels
hormone levels in plasma
Time frame: 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
Time frame: 6-month
Menses recovery (YES/NO)
If menses recovery is noted by patients should be informed and recorded
Time frame: 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
Time frame: 6-12 months
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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