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

February 22, 2023 updated by: Genesis Athens Clinic

Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal Women

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

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 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 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
        • Contact:
          • Konstantinos Pantos, MD,PhD

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

40 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 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
Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.
Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion
Autologous PRP intra ovarian infusion
Other Names:
  • PRP
  • Platelet Rich Plasma
Placebo Comparator: Participants receiving Platelet Free Plasma (PFP)
Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.
Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion
Autologous PFP intra ovarian infusion
Other Names:
  • PFP
  • Platelet Free Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Restoration of menstrual cycle regularity
Time Frame: Three months
Regular Menstrual cycle
Three months

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 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
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
Serum Estradiol levels
Time Frame: Follow-up period of three months entailing monthly evaluation
Serum etsradiol 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

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

  • Study Director: Agni Pantou, MD, Obstetrician Gynecologist

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)

June 13, 2019

Primary Completion (Anticipated)

January 30, 2025

Study Completion (Anticipated)

July 30, 2025

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 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- Perimenopause

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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