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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
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.
IVI Madrid
Madrid, Spain
IVI Valencia
Valencia, Spain
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
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