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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 hormonal profile of women in menopause.
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 menopausal 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 restoring ovarian tissue functionality in menopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving PRP treatment | Experimental | Menopausal women minimum 45 years of age, receiving ovarian PRP treatment. |
|
| Control Group: Participants receiving Platelet Free Plasma | Placebo Comparator | Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous PRP intra ovarian infusion | Biological | Autologous PRP intra ovarian infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of menstrual cycle | Menstrual cycle restoration | 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 estradiol levels | Serum estradiol 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 | Contact | +306974447702 | agni.pantou@genesisathens.gr |
| Name | Affiliation | Role |
|---|---|---|
| Agni Pantou, MD | Centre of Human Reproduction, Genesis Athens Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis AC | Recruiting | Athens | 15232 | Greece |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Autologous PFP intra ovarian infusion | Biological | Autologous PFP intra ovarian infusion |
|
| Follow-up period of three months entailing monthly evaluation |
| Serum LH levels | Serum LH levels evaluated monthly for three consecutive months. | Follow-up period of three months entailing monthly evaluation |
| Serum progesterone 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 |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |