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

December 20, 2024 updated by: Genesis Athens Clinic

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 15232
        • Recruiting
        • Genesis AC
        • Contact:
        • Principal Investigator:
          • Konstantinos Pantos, MD,PhD
        • Principal Investigator:
          • Agni Pantou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receiving PRP treatment
Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.
Biological: Autologous PRP intra ovarian infusion
Autologous PRP intra ovarian infusion
Placebo Comparator: Control Group: Participants receiving Platelet Free Plasma
Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.
Biological: Autologous PFP intra ovarian infusion
Autologous PFP intra ovarian infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of menstrual cycle
Time Frame: Three months
Menstrual cycle restoration
Three months
Serum FSH levels
Time Frame: Follow-up period of three months entailing monthly evaluation
Serum FSH levels evaluated monthly for three consecutive months.
Follow-up period of three months entailing monthly evaluation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum AMH levels
Time Frame: Follow-up period of three months entailing monthly evaluation
Serum AMH levels evaluated monthly for three consecutive months.
Follow-up period of three months entailing monthly evaluation
Serum estradiol levels
Time Frame: Follow-up period of three months entailing monthly evaluation
Serum estradiol levels evaluated monthly for three consecutive months.
Follow-up period of three months entailing monthly evaluation
Serum LH levels
Time Frame: Follow-up period of three months entailing monthly evaluation
Serum LH levels evaluated monthly for three consecutive months.
Follow-up period of three months entailing monthly evaluation
Serum progesterone levels
Time Frame: Follow-up period of three months entailing monthly evaluation
Serum progesterone levels evaluated monthly for three consecutive months.
Follow-up period of three months entailing monthly evaluation
Antral Follicle Count
Time Frame: Follow-up period of three months entailing monthly evaluation
AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months.
Follow-up period of three months entailing monthly evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genesis Athens Clinic

Collaborators

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: Agni Pantou, MD, Centre of Human Reproduction, Genesis Athens Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2019

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP - Menopausal women

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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