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

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

Phase

2/3

Condition

Post Menopause

Hot Flash

Perimenopause

Treatment

Autologous Platelet Rich Plasma

Placebo-Platelet Free Plasma

Clinical Study ID

NCT04031456
PRP- POI
  • Ages 25-39
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age < 40 years, presenting with amenorrhea or menstrual cycle irregularities for atleast four months, and elevated FSH levels >25 IU/L recorded on two occasions >4weeks apart

  • Normal Karyotype: 46, XX

  • 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

  • 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 Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Autologous Platelet Rich Plasma
Phase: 2/3
Study Start date:
July 30, 2019
Estimated Completion Date:
July 30, 2026

Study 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.

Connect with a study center

  • Genesis AC

    Athens, 15232
    Greece

    Active - Recruiting

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