Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal Women

Conditions
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Infertility, Female, Perimenopausal Disorder, Menstrual Cycle Abnormal

Intervention / Treatment
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* Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion
* Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels. Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment. Willing to comply with study requirements Exclusion Criteria: Any pathological disorder related to reproductive system anatomy Amenorrhea Endometriosis Adenomyosis Fibroids and adhesions Infections in reproductive system Current or previous diagnosis of cancer in reproductive system History of familiar cancer in reproductive system Severe male factor infertility Prior referral for PGT Ovarian inaccessibility Previous POI diagnosis -Endocrinological disorders (Hypothalamus- Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome) BMI>30 kg/m2 or BMI<18.5 kg/m2 Systematic autoimmune disorders

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants receiving PRP treatment<br>Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion. | Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion<br>* Autologous PRP intra ovarian infusion<br>* Other names: Platelet Rich Plasma;|
| Placebo Comparator: Participants receiving Platelet Free Plasma (PFP)<br>Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion. | Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion<br>* Autologous PFP intra ovarian infusion<br>* Other names: Platelet Free Plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |