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RecruitingNCT05181748PRPPORUpdated Jul 8, 2026

Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

A Phase 2/3 interventional study of Autologous platelet rich plasma in Poor Response to Ovulation Induction, Infertility, Female and Ovarian Insufficiency, 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.

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

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Jan 2019, registered Dec 2021).
  • Started Jan 2019; still recruiting 7 years 9 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
35 Years to 47 Years
Sex
Female
01

Study summary

Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.

Read the detailed description

Despite recent advances in reproductive medicine, poor ovarian response (POR) management is still considered to be very challenging. Commonly, POR patients present with reduced ovarian reserve and poor ovarian stimulation performance. The POR cycles are characterized by a very limited number of retrieved oocytes, subsequently leading to poor embryo formation and thus to high cycle cancelation rate. Despite the fact that POR constitutes a multifactorial condition, it is well demonstrated that advanced maternal age (AMA) is the most significant contributor of POR. As maternal age increases, reduction of neo-angiogenesis in ovaries is observed, leading to accelerated follicular loss. Considering that PRP contains several growth factors such as vascular endothelial growth factor (VEGF) and cytokines, it has been proposed that intraovarian infusion of autologous PRP could restore the ovarian niche microenvironment, increasing ovarian response to external gonadotropin stimulation. However, limited data are available with regards to PRP efficiency in POR patients, which are mainly originating from pilot or small cohort studies. This interventional non-randomised open-label study aims to investigate the effect of autologous PRP intraovarian infusion on improving POR patient performance by studying a large and well-controlled POR population.

02

Conditions studied

  • Poor Response to Ovulation Induction
  • Infertility, Female
  • Ovarian Insufficiency
  • Ovarian Failure
  • Reproductive Sterility
  • Ovary; Anomaly

Keywords

  • Autologous platelet rich plasma intraovarian infusion
  • Assisted reproduction
  • PRP
  • In vitro fertilization
  • Ovarian functionality improvement
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
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):

  1. Age ≥ 40 years
  2. AMH \< 1.1 ng/ml OR AFC \< 7
  3. ≤ 3 oocytes with a conventional stimulation protocol

    • Discontinuation of any complementary/ treatment including hormone replacement and acupuncture, 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 Preimplantation Genetic Testing (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
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Experimental: Group of participants receiving PRP treatment

    Women presenting with POR, treated with autologous PRP intraovarian infusion during the mid-luteal phase, undergoing a subsequent stimulated fresh ET-ICSI cycle on the first month following PRP infusion

    Biological: Autologous platelet rich plasma

  • No intervention
    Control Group: Group of participants receiving standard protocol

    Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle

Interventions

  • Preparation of PRP will be performed immediately following blood sample collection. Blood samples will be collected from the median antebrachial vein. PRP will be prepared according to the manufacturer's instructions employing a Regen Autologous Cellular Regeneration (ACR®-C) Kit (Regen Laboratory, Le Mont-sur-Lausanne, Switzerland). Approximately 60 mL of the patient's peripheral blood will be required in order to yield the required volume of PRP. The goal concentration of platelets in PRP is approximately 1.000.000 platelets/µL. The technique of PRP intraovarian infusion resembles the transvaginal paracentesis performed during the oocyte pick-up procedure. Briefly, both ovaries are visualized via transvaginal ultrasound monitoring, and they are intramedullary injected on multiple sites using a 17-gauge single lumen needle, with the patient under inhaled minimal sedation.

    Also known as: PRP

06

What researchers measure

Primary outcomes

  1. Number of oocytes retrieved

    Number of oocytes retrieved following controlled ovarian stimulation in the first fresh ICSI-ET cycle performed on the first menstrual cycle following intervention

    Time frame: 34-36 hours following ovulation triggering

  2. Anti-Müllerian Hormone Levels (AMH)

    Serum anti-müllerian hormone (AMH) levels evaluated in the first menstrual cycle following intervention

    Time frame: On day 2-3 of the first menstrual cycle post intervention

Secondary outcomes

  1. Clinical pregnancy rate

    Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the first menstrual cycle after intervention

    Time frame: 6-7 weeks following last menstruation

  2. Antral Follicle Count (AFC)

    Antral Follicle Count (AFC) evaluated in the first menstrual cycle following intervention

    Time frame: On day 2-3 of the first menstrual cycle post intervention

07

Study locations

1 of 1 sites recruiting
  • Genesis Athens Clinic
    Athens, Attica 15232, Greece
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will be provided upon reasonable request, following authorization by the Scientific and Ethical Board of Genesis Athens Clinic

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2019 (actual). Primary completion is estimated for Dec 2027, 107 months after the start.

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

Registered
Dec 20, 2021
First posted
Jan 6, 2022
StartActual
Jan 23, 2019
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 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 ↗
10

Registry details

Key details

Study ID
NCT05181748
Lead sponsor
Genesis Athens Clinic
Responsible party
Sponsor
First posted
Jan 6, 2022
Start date
Jan 23, 2019
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 8, 2026

Study contacts

Agni Pantou, M.D
Contact
agni.pantou@genesisathens.gr
+306974447702
Konstantinos Pantos, M.D., Ph.D
Contact
info@pantos.gr
+302106894326
Agni Pantou, M.D
principal investigator · Genesis Athens Clinic

Oversight

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

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