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RecruitingNCT03916978PRPUpdated Jul 8, 2026

Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women

A Phase 2/3 interventional study of Autologous PRP intra ovarian infusion and Autologous PFP intra ovarian infusion in Infertility, Female, Anovulatory Infertility and Menopause, sponsored by Genesis Athens Clinic. Recruiting at 1 site in Greece. Open to female participants aged 45 Years to 55 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
45 Years to 55 Years
Sex
Female
01

Study summary

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

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 menopausal 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 restoring ovarian tissue functionality in menopausal women.

02

Conditions studied

  • Infertility, Female
  • Anovulatory Infertility
  • Menopause
  • Amenorrhea

Keywords

  • Ovarian rejuvenation
  • Ovarian reactivation; ovulation
03

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 45-55 years old
  • Amenorrhea for at least 12 months
  • 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
  • Previous POI diagnosis
  • Abnormal karyotype
  • Endometriosis
  • Adenomyosis
  • Fibroids and adhesions
  • Infections in reproductive system
  • Current or previous diagnosis of reproductive system cancer
  • 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

    Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.

    Biological: Autologous PRP intra ovarian infusion

  • Placebo comparator
    Control Group: Participants receiving Platelet Free Plasma

    Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.

    Biological: Autologous PFP intra ovarian infusion

Interventions

  • BiologicalAutologous PRP intra ovarian infusion

    Autologous PRP intra ovarian infusion

  • BiologicalAutologous PFP intra ovarian infusion

    Autologous PFP intra ovarian infusion

05

What researchers measure

Primary outcomes

  1. Restoration of menstrual cycle

    Menstrual cycle restoration

    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 AMH levels evaluated monthly for three consecutive months.

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

  2. Serum estradiol levels

    Serum estradiol levels evaluated monthly for three consecutive months.

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

  3. Serum LH levels

    Serum LH levels evaluated monthly for three consecutive months.

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

  4. Serum progesterone 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 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
    • Agni Pantou, MD · Contact · agni.pantou@genesisathens.gr
    • Agni Pantou, MD · Principal investigator
    • Konstantinos Pantos, MD,PhD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03916978
Lead sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
Responsible party
Sponsor
First posted
Apr 16, 2019
Start date
May 21, 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
Contact
agni.pantou@genesisathens.gr
+306974447702
Agni Pantou, MD
principal investigator · Centre of Human Reproduction, Genesis Athens Clinic

Oversight

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

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