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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal women. 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 improving ovarian tissue functionality in perimenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving PRP treatment | Experimental | Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion. |
|
| Participants receiving Platelet Free Plasma (PFP) | Placebo Comparator | Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet Rich Plasma (PRP) intra ovarian infusion | Biological | Autologous PRP intra ovarian infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of menstrual cycle regularity | 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 AMH 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 | agni.pantou@genesisathens.gr |
| Name | Affiliation | Role |
|---|---|---|
| Agni Pantou, MD | Obstetrician Gynecologist | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis AC | Recruiting | Athens | 15232 | Greece |
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| Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion | Other | Autologous PFP intra ovarian infusion |
|
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| Follow-up period of three months entailing monthly evaluation |
| Serum Estradiol levels | Serum etsradiol 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 evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months. | Follow-up period of three months entailing monthly evaluation |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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