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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03951194
Other study ID # PRP- Perimenopause
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 13, 2019
Est. completion date July 30, 2025

Study information

Verified date February 2023
Source Genesis Athens Clinic
Contact Mara Simopoulou, PhD
Phone +306979234100
Email marasimopoulou@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 50 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Greece Genesis AC Athens

Sponsors (2)

Lead Sponsor Collaborator
Genesis Athens Clinic National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Restoration of menstrual cycle regularity Regular Menstrual cycle Three months
Primary Serum FSH levels Serum FSH levels evaluated monthly for three consecutive months. Follow-up period of three months entailing monthly evaluation
Secondary Serum AMH levels Serum AMH levels evaluated monthly for three consecutive months. Follow-up period of three months entailing monthly evaluation
Secondary Serum LH levels Serum LH levels evaluated monthly for three consecutive months. Follow-up period of three months entailing monthly evaluation
Secondary Serum Estradiol levels Serum etsradiol levels evaluated monthly for three consecutive months. Follow-up period of three months entailing monthly evaluation
Secondary Serum Progesteron levels Serum progesterone levels evaluated monthly for three consecutive months. Follow-up period of three months entailing monthly evaluation
Secondary 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
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