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RecruitingNCT04031456PRPUpdated Jul 8, 2026

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

A Phase 2/3 interventional study of Autologous Platelet Rich Plasma and Placebo-Platelet Free Plasma in Menopause, Premature, Menopause Related Conditions and Menopausal Syndrome, sponsored by Genesis Athens Clinic. Recruiting at 1 site in Greece. Open to female participants aged 25 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Genesis Athens Clinic · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
25 Years to 39 Years
Sex
Female
01

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.

Read the 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.

02

Conditions studied

  • Menopause, Premature
  • Menopause Related Conditions
  • Menopausal Syndrome
  • Premature Ovarian Failure
  • Ovarian Failure, Premature
03

Who can participate

Ages eligible
25 Years to 39 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BiologicalAutologous Platelet Rich Plasma

    Autologous PRP intra ovarian infusion

    Also known as: PRP, Platelet Rich Plasma

  • BiologicalPlacebo-Platelet Free Plasma

    Autologous PFP intra ovarian infusion

    Also known as: PFP

05

What researchers measure

Primary outcomes

  1. Restoration of menstrual cycle

    Regular menstrual cycle

    Time frame: Three months

  2. Serum FSH levels

    Serum FSH levels evaluated monthly for three consecutive months

    Time frame: Follow-up period of three months entailing monthly evaluation

Secondary outcomes

  1. Serum AMH levels

    Serum ΑΜΗ levels evaluated monthly for three consecutive months

    Time frame: Follow-up period of three months entailing monthly evaluation

  2. Serum LH levels

    Serum LH levels evaluated monthly for three consecutive months

    Time frame: Follow-up period of three months entailing monthly evaluation

  3. Serum Estradiol levels

    Serum estradiol levels evaluated monthly for three consecutive months

    Time frame: Follow-up period of three months entailing monthly evaluation

  4. Serum Progesteron levels

    Serum progesterone levels evaluated monthly for three consecutive months

    Time frame: Follow-up period of three months entailing monthly evaluation

  5. Antral Follicle Count (AFC)

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

    Time frame: Follow-up period of three months entailing monthly evaluation

06

Study locations

1 of 1 sites recruiting
  • Genesis AC
    Athens, 15232, Greece
    • Mara Simopoulou, PhD · Contact
    • Agni Pantou, MD · Principal investigator
    • Konstantinos Pantos, MD, PhD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT04031456
Lead sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
Responsible party
Sponsor
First posted
Jul 24, 2019
Start date
Jul 30, 2019
Primary completion
Jan 30, 2027 (estimated)
Completion
Jul 30, 2028 (estimated)
Last update
Jul 8, 2026

Study contacts

Mara Simopoulou, PhD
Contact
marasimopoulou@hotmail.com
+306979234100
Agni Pantou, MD, PhD Candidate
Contact

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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