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

Last updated: December 20, 2024
Sponsor: Genesis Athens Clinic
Overall Status: Active - Recruiting

Phase

2/3

Condition

Infertility

Treatment

Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion

Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

Clinical Study ID

NCT03951194
PRP- Perimenopause
  • Ages 40-50
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women ≥40 years of age, presenting with cycle irregularities while fulfilling atleast one of the respective two criteria: more than seven days difference inmenstrual cycle duration between two consecutive cycles OR, presence of a menstrualcycle duration over sixty days and progressive elevation of FSH levels.

  • Discontinuation of any complementary/adjuvant treatment including hormonereplacement, acupuncture, and botanotherapy, for at least three months prior torecruitment.

  • Willing to comply with study requirements

Exclusion

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 Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion
Phase: 2/3
Study Start date:
June 13, 2019
Estimated Completion Date:
July 30, 2025

Study 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.

Connect with a study center

  • Genesis AC

    Athens, 15232
    Greece

    Active - Recruiting

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