Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

Premature Ovarian Failure Clinical Trial

— PRP  

Official title:

Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04031456
• Other study ID #: PRP- POI
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 30, 2019
• Est. completion date: July 30, 2026

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 restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 39 Years

Eligibility

Inclusion Criteria:

• 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

• Normal Karyotype: 46, XX

• 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

• AMH > 8 pmol/L

• 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

• 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

• Menopausal Syndrome
• Menopause Related Conditions
• Menopause, Premature
• Ovarian Failure, Premature
• Premature Birth
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Biological:
• Autologous Platelet Rich Plasma
Autologous PRP intra ovarian infusion
• Placebo-Platelet Free Plasma
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	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 ??? 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 estradiol 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)	AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months	Follow-up period of three months entailing monthly evaluation