4-step ASCOT in POI Women to Promote Follicular Rescue
Premature Ovarian Insufficiency
About this trial
This is an interventional treatment trial for Premature Ovarian Insufficiency
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
Sites / Locations
- IVI Madrid
- IVI Valencia
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control arm
4-step ASCOT arm
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.