Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women

Study Overview
=================
Brief Summary
-----------------
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

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 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.

Official Title
-----------------
Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women

Conditions
-----------------
Infertility, Female, Anovulatory Infertility, Menopause, Amenorrhea

Intervention / Treatment
-----------------
* Biological: Autologous PRP intra ovarian infusion
* Biological: Autologous PFP intra ovarian infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 45-55 years old Amenorrhea for at least 12 months 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 Previous POI diagnosis Abnormal karyotype Endometriosis Adenomyosis Fibroids and adhesions Infections in reproductive system Current or previous diagnosis of reproductive system cancer History of familiar cancer in reproductive system Severe male factor infertility Prior referral for PGT Ovarian inaccessibility 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
-----------------
Minimum Age: 45 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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>Menopausal women minimum 45 years of age, receiving ovarian PRP treatment. | Biological: Autologous PRP intra ovarian infusion<br>* Autologous PRP intra ovarian infusion<br>|
| Placebo Comparator: Control Group: Participants receiving Platelet Free Plasma<br>Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion. | Biological: Autologous PFP intra ovarian infusion<br>* Autologous PFP intra ovarian infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

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 estradiol levels | Serum estradiol 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 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian rejuvenation, Ovarian reactivation; ovulation