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

Infertility, Female Clinical Trial

— PRP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03951194
• Other study ID #: PRP- Perimenopause
• Status: Recruiting
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Menstrual Cycle Abnormal
• Perimenopausal Disorder

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