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RecruitingNCT03951194PRPUpdated Jul 8, 2026

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

A Phase 2/3 interventional study of Autologous Platelet Rich Plasma (PRP) intra ovarian infusion and Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion in Infertility, Female, Perimenopausal Disorder and Menstrual Cycle Abnormal, sponsored by Genesis Athens Clinic. Recruiting at 1 site in Greece. Open to female participants aged 40 Years to 50 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
40 Years to 50 Years
Sex
Female
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Infertility, Female
  • Perimenopausal Disorder
  • Menstrual Cycle Abnormal

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03

Who can participate

Ages eligible
40 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

    Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.

    Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

  • Placebo comparator
    Participants receiving Platelet Free Plasma (PFP)

    Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.

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

Interventions

  • BiologicalAutologous Platelet Rich Plasma (PRP) intra ovarian infusion

    Autologous PRP intra ovarian infusion

    Also known as: PRP, Platelet Rich Plasma

  • OtherPlacebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion

    Autologous PFP intra ovarian infusion

    Also known as: PFP, Platelet Free Plasma

05

What researchers measure

Primary outcomes

  1. Restoration of menstrual cycle regularity

    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 AMH 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 etsradiol 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 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
    Recruiting
07

Registry details

Key details

Study ID
NCT03951194
Lead sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
Responsible party
Sponsor
First posted
May 15, 2019
Start date
Jun 13, 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
agni.pantou@genesisathens.gr
Agni Pantou, MD
study director · Obstetrician Gynecologist

Oversight

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

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