Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women

Phase 2

Recruiting

• Conditions: Anovulatory Infertility; Menopause; Infertility, Female; Amenorrhea
• Interventions: Biological: Autologous PFP intra ovarian infusion; Biological: Autologous PRP intra ovarian infusion

• Registration Number: NCT03916978
• Lead Sponsor: Genesis Athens Clinic

Brief Summary

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

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 menopausal 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 restoring ovarian tissue functionality in menopausal women.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-16
• Study Start: 2019-05-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-01-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

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

Inclusion Criteria

• Age between 45-55 years old
• Amenorrhea for at least 12 months
• 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
• Previous POI diagnosis
• Abnormal karyotype
• Endometriosis
• Adenomyosis
• Fibroids and adhesions
• Infections in reproductive system
• Current or previous diagnosis of reproductive system cancer
• 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
Control Group: Participants receiving Platelet Free Plasma	Autologous PFP intra ovarian infusion	Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.
Participants receiving PRP treatment	Autologous PRP intra ovarian infusion	Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.

Primary Outcome Measures

Name	Time	Method
Restoration of menstrual cycle	Three months	Menstrual cycle restoration
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 progesterone levels	Follow-up period of three months entailing monthly evaluation	Serum progesterone 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 AMH levels	Follow-up period of three months entailing monthly evaluation	Serum AMH 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