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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, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and fresh ET-ICSI cycles' performance in regard to patients presenting with POR. 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 POR patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of participants receiving PRP treatment | Experimental | Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period. |
|
| Control Group: participants receiving Platelet Free Plasma | Placebo Comparator | Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Biological | Autologous PRP intra ovarian infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period | 34-36 hours following hCG administration |
| AMH levels | Serum AMH levels evaluated monthly for three consecutive months | Follow-up period of three months entailing monthly evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period | 6-7 weeks following last menstruation |
| Antral Follicle Count |
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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 | +306974447702 | agni.pantou@genesisathens.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis AC | Recruiting | Athens | 15232 | Greece |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo |
| Biological |
Autologous PFP intra ovarian infusion |
|
AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months
| Follow-up period of three months entailing monthly evaluation |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |