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

Sponsor
Genesis Athens Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04031456
Collaborator
National and Kapodistrian University of Athens (Other)
100
Enrollment
1
Location
2
Arms
54
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Autologous Platelet Rich Plasma
  • Biological: Placebo-Platelet Free Plasma
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients
Actual Study Start Date :
Jul 30, 2019
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Restoration of menstrual cycle [Three months]

      Regular menstrual cycle

    2. Serum FSH levels [Follow-up period of three months entailing monthly evaluation]

      Serum FSH levels evaluated monthly for three consecutive months

    Secondary Outcome Measures

    1. Serum AMH levels [Follow-up period of three months entailing monthly evaluation]

      Serum ΑΜΗ levels evaluated monthly for three consecutive months

    2. Serum LH levels [Follow-up period of three months entailing monthly evaluation]

      Serum LH levels evaluated monthly for three consecutive months

    3. Serum Estradiol levels [Follow-up period of three months entailing monthly evaluation]

      Serum estradiol levels evaluated monthly for three consecutive months

    4. Serum Progesteron levels [Follow-up period of three months entailing monthly evaluation]

      Serum progesterone levels evaluated monthly for three consecutive months

    5. Antral Follicle Count (AFC) [Follow-up period of three months entailing monthly evaluation]

      AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Genesis AC Athens Greece 15232

    Sponsors and Collaborators

    • Genesis Athens Clinic
    • National and Kapodistrian University of Athens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Genesis Athens Clinic
    ClinicalTrials.gov Identifier:
    NCT04031456
    Other Study ID Numbers:
    • PRP- POI
    First Posted:
    Jul 24, 2019
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Premature Birth
    Primary Ovarian Insufficiency
    Menopause, Premature

    Study Results

    No Results Posted as of Dec 14, 2021