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

February 22, 2023 updated by: Genesis Athens Clinic

Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients

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

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 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 Type

Interventional

Enrollment (Anticipated)

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 Locations

  • Greece
      • Athens, Greece, 15232
        • Recruiting
        • Genesis AC

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

25 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 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
Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion
Biological: Autologous Platelet Rich Plasma
Autologous PRP intra ovarian infusion
Other Names:
  • PRP
  • Platelet Rich Plasma
Placebo Comparator: Participants receiving Platelet Free Plasma (PFP) treatment
Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion
Biological: Placebo-Platelet Free Plasma
Autologous PFP intra ovarian infusion
Other Names:
  • PFP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of menstrual cycle
Time Frame: Three months
Regular menstrual cycle
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 ΑΜΗ 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 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 Progesteron 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 (AFC)
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

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)

July 30, 2019

Primary Completion (Anticipated)

January 30, 2026

Study Completion (Anticipated)

July 30, 2026

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP- POI

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.

Clinical Trials on Menopause, Premature

Clinical Trials on Autologous Platelet Rich Plasma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe