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

Menopause Clinical Trial

— PRP  

Official title:

Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Menopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916978
• Other study ID #: PRP - Menopausal women
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 21, 2019
• Est. completion date: July 30, 2026

Study information

• Verified date: September 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 hormonal profile of women in menopause.

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.

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: 45 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Amenorrhea
• Anovulatory Infertility
• Infertility
• Infertility, Female
• Menopause

Intervention

Biological:
• Autologous PRP intra ovarian infusion
Autologous PRP intra ovarian infusion
• Autologous 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	Menstrual cycle restoration	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 estradiol levels	Serum estradiol 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 progesterone 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