Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
Study Details
Study Description
Brief Summary
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 2/Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Participants receiving PRP treatment Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion |
Biological: Autologous Platelet Rich Plasma
Autologous PRP intra ovarian infusion
Other Names:
|
Placebo Comparator: Participants receiving Platelet Free Plasma (PFP) treatment Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion |
Biological: Placebo-Platelet Free Plasma
Autologous PFP intra ovarian infusion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Restoration of menstrual cycle [Three months]
Regular menstrual cycle
- Serum FSH levels [Follow-up period of three months entailing monthly evaluation]
Serum FSH levels evaluated monthly for three consecutive months
Secondary Outcome Measures
- Serum AMH levels [Follow-up period of three months entailing monthly evaluation]
Serum ΑΜΗ levels evaluated monthly for three consecutive months
- Serum LH levels [Follow-up period of three months entailing monthly evaluation]
Serum LH levels evaluated monthly for three consecutive months
- Serum Estradiol levels [Follow-up period of three months entailing monthly evaluation]
Serum estradiol levels evaluated monthly for three consecutive months
- Serum Progesteron levels [Follow-up period of three months entailing monthly evaluation]
Serum progesterone levels evaluated monthly for three consecutive months
- Antral Follicle Count (AFC) [Follow-up period of three months entailing monthly evaluation]
AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age < 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels >25 IU/L recorded on two occasions >4 weeks apart
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Normal Karyotype: 46, XX
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Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
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Willing to comply with study requirements
Exclusion Criteria:
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Any pathological disorder related to reproductive system anatomy
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AMH > 8 pmol/L
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Endometriosis
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Adenomyosis
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Fibroids and adhesions
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Infections in reproductive system
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Current or previous diagnosis of cancer in reproductive system
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History of familiar cancer in reproductive system
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Severe male factor infertility
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Prior referral for PGT
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Ovarian inaccessibility
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Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
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BMI>30 kg/m2 or BMI<18.5 kg/m2
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Systematic autoimmune disorders
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Genesis AC | Athens | Greece | 15232 |
Sponsors and Collaborators
- Genesis Athens Clinic
- National and Kapodistrian University of Athens
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRP- POI