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

Phase 2

Recruiting

• Conditions: Menstrual Cycle Abnormal; Infertility, Female; Perimenopausal Disorder
• Interventions: Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

• Registration Number: NCT03951194
• Lead Sponsor: Genesis Athens Clinic

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-15
• Study Start: 2019-06-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-01-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participants receiving PRP treatment	Autologous Platelet Rich Plasma (PRP) intra ovarian infusion	Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum AMH levels	Follow-up period of three months entailing monthly evaluation	Serum AMH levels evaluated monthly for three consecutive months.
Serum Estradiol levels	Follow-up period of three months entailing monthly evaluation	Serum etsradiol 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.
Serum LH levels	Follow-up period of three months entailing monthly evaluation	Serum LH levels evaluated monthly for three consecutive months.
Antral Follicle Count	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