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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

From the registry’s dates

  • Started Jun 2019; still recruiting 7 years 4 months later.
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

Browse trials for

03

In context

Infertility, Female

552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 378 interventional studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

Genesis Athens Clinic is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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/ 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)
  • >30 kg/m2 or BMI\<18.5 kg/m2
  • Systematic disorders
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2019 (actual). Primary completion is estimated for Jan 2027, 91 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2017
First posted
May 15, 2019
StartActual
Jun 13, 2019
Primary completionEst.
Jan 30, 2027
CompletionEst.
Jul 30, 2028
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03951194
Lead sponsor
Genesis Athens Clinic
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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