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

Phase 2

Recruiting

• Conditions: Menopause Related Conditions; Menopause, Premature; Ovarian Failure, Premature; Menopausal Syndrome; Premature Ovarian Failure
• Interventions: Biological: Placebo-Platelet Free Plasma; Biological: Autologous Platelet Rich Plasma

• Registration Number: NCT04031456
• Lead Sponsor: Genesis Athens Clinic

Brief Summary

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

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 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.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-24
• Study Start: 2019-07-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-01-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants receiving Platelet Free Plasma (PFP) treatment	Placebo-Platelet Free Plasma	Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion
Participants receiving PRP treatment	Autologous Platelet Rich Plasma	Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion

Primary Outcome Measures

Name	Time	Method
Restoration of menstrual cycle	Three months	Regular menstrual cycle
Serum FSH levels	Follow-up period of three months entailing monthly evaluation	Serum FSH levels evaluated monthly for three consecutive months

Secondary Outcome Measures

Name	Time	Method
Serum AMH levels	Follow-up period of three months entailing monthly evaluation	Serum ΑΜΗ levels evaluated monthly for three consecutive months
Serum LH levels	Follow-up period of three months entailing monthly evaluation	Serum LH levels evaluated monthly for three consecutive months
Serum Estradiol levels	Follow-up period of three months entailing monthly evaluation	Serum estradiol levels evaluated monthly for three consecutive months
Serum Progesteron levels	Follow-up period of three months entailing monthly evaluation	Serum progesterone levels evaluated monthly for three consecutive months
Antral Follicle Count (AFC)	Follow-up period of three months entailing monthly evaluation	AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months

Trial Locations

Locations (1)

Genesis AC; 🇬🇷 Athens, Greece