Status:
COMPLETED
4-step ASCOT in POI Women to Promote Follicular Rescue
Lead Sponsor:
Fundación IVI
Collaborating Sponsors:
Instituto Valenciano de Infertilidad, IVI VALENCIA
IVI Madrid
Conditions:
Premature Ovarian Insufficiency
Eligibility:
FEMALE
18-38 years
Phase:
PHASE3
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04475744
Start Date
March 5 2021
End Date
October 30 2023
Last Update
February 28 2024
Active Locations (2)
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1
IVI Madrid
Madrid, Spain
2
IVI Valencia
Valencia, Spain