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RecruitingNCT03937661PRPUpdated Jul 8, 2026

Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders

A Phase 2/3 interventional study of PRP and Placebo in Ovary; Anomaly and Infertility, Female, sponsored by Genesis Athens Clinic. Recruiting at 1 site in Greece. Open to female participants aged 35 Years to 47 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Primary conditionInfertility, FemaleRegistry: Congenital AbnormalitiesReclassifiedWhy we changed it
Registry
Congenital Abnormalities — the first condition term the registry derived for this study.
ClinicalTrials.gg
Infertility, Female
Why
  1. Congenital Abnormalities is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Infertility, Female.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

From the registry’s dates

  • Started May 2019; still recruiting 7 years 6 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
35 Years to 47 Years
Sex
Female
01

Study summary

Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).

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 fresh ET-ICSI cycles' performance in regard to patients presenting with POR. 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 POR patients.

02

Conditions studied

  • Ovary; Anomaly
  • Infertility, Female

Browse trials for

03

In context

Infertility, Female Reclassified

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.

Compared within Infertility, Female, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
35 Years to 47 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

  • Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following)
  • Age ≥ 40 years
  • AMH \< 1.1 ng/ml OR AFC \< 7
  • ≤ 3 oocytes with a conventional stimulation protocol)
  • 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
  • Cycle irregularities
  • 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 -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
    Group of participants receiving PRP treatment

    Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period.

    Biological: PRP

  • Placebo comparator
    Control Group: participants receiving Platelet Free Plasma

    Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period

    Biological: Placebo

Interventions

  • BiologicalPRP

    Autologous PRP intra ovarian infusion

  • BiologicalPlacebo

    Autologous PFP intra ovarian infusion

06

What researchers measure

Primary outcomes

  1. Number of oocytes retrieved

    Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period

    Time frame: 34-36 hours following hCG administration

  2. AMH levels

    Serum AMH levels evaluated monthly for three consecutive months

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

Secondary outcomes

  1. Clinical pregnancy rate

    Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period

    Time frame: 6-7 weeks following last menstruation

  2. 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

Updates

Tracking since Sep 25, 2026
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
NCT03937661
Lead sponsor
Genesis Athens Clinic
Responsible party
Sponsor
First posted
May 6, 2019
Start date
May 6, 2019
Primary completion
Jan 30, 2027 (estimated)
Completion
Aug 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
+306974447702

Oversight

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

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Studies of the drug tested here: Platelet rich plasma

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