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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in POI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving PRP treatment | Experimental | Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion |
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| Participants receiving Platelet Free Plasma (PFP) treatment | Placebo Comparator | Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet Rich Plasma | Biological | Autologous PRP intra ovarian infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of menstrual cycle | Regular menstrual cycle | Three months |
| Serum FSH levels | Serum FSH levels evaluated monthly for three consecutive months | Follow-up period of three months entailing monthly evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Serum AMH levels | Serum ΑΜΗ levels evaluated monthly for three consecutive months | Follow-up period of three months entailing monthly evaluation |
| Serum LH levels | Serum LH levels evaluated monthly for three consecutive months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mara Simopoulou, PhD | Contact | +306979234100 | marasimopoulou@hotmail.com | |
| Agni Pantou, MD, PhD Candidate | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis AC | Recruiting | Athens | 15232 | Greece |
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| Placebo-Platelet Free Plasma | Biological | Autologous PFP intra ovarian infusion |
|
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| Follow-up period of three months entailing monthly evaluation |
| Serum Estradiol levels | Serum estradiol levels evaluated monthly for three consecutive months | Follow-up period of three months entailing monthly evaluation |
| Serum Progesteron levels | Serum progesterone levels evaluated monthly for three consecutive months | Follow-up period of three months entailing monthly evaluation |
| Antral Follicle Count (AFC) | AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months | Follow-up period of three months entailing monthly evaluation |
| ID | Term |
|---|---|
| D008594 | Menopause, Premature |
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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