Poor Response to Ovulation InductionPhase 2/3PRPPORNCT05181748
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
A Phase 2/3 study testing Autologous platelet rich plasma in people with Poor Response to Ovulation Induction and Infertility, Female, run by Genesis Athens Clinic at 1 site in Greece.
Trial 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 more about this study
- Who is it for?
- Ages 35 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Response to Ovulation Induction, Infertility, Female, Ovarian Insufficiency
- What is being tested?
- Autologous platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 23 Jan 2019to 31 Dec 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.
- Willing to comply with study requirements
Who cannot join
- Any pathological disorder related to reproductive system anatomy
- Cycle irregularities
- Amenorrhea
- Endometriosis
- Adenomyosis
- Fibroids and adhesions
Show all 14Show fewer
- 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)
- BMI>30 kg/m2 or BMI<18.5 kg/m2
- Systematic autoimmune disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Genesis Athens Clinic
Athens, Attica, 15232
Agni Pantou, M.D, +306974447702, agni.pantou@genesisathens.gr
Agni Pantou, M.D
About this study
Official title: Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients
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.
- Conditions
- Poor Response to Ovulation Induction, Infertility, Female, Ovarian Insufficiency, Ovarian Failure, Reproductive Sterility, Ovary; Anomaly
- Being tested
- Autologous platelet rich plasma
- Keywords
- Autologous platelet rich plasma intraovarian infusion, Assisted reproduction, PRP, In vitro fertilization, Ovarian functionality improvement
- Medical subject headings
- Infertility, Female, Infertility, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet rich plasmaBiological
Also called PRP
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group of participants receiving PRP treatment | Experimental | 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 Receives: Biological: Autologous platelet rich plasma |
| Control Group: Group of participants receiving standard protocol | No intervention | Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 34-36 hours following ovulation triggering
Anti-Müllerian Hormone Levels (AMH)
Serum anti-müllerian hormone (AMH) levels evaluated in the first menstrual cycle following intervention
Measured: On day 2-3 of the first menstrual cycle post intervention
Secondary outcomes (2)
Clinical pregnancy rate
Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the first menstrual cycle after intervention
Measured: 6-7 weeks following last menstruation
Antral Follicle Count (AFC)
Antral Follicle Count (AFC) evaluated in the first menstrual cycle following intervention
Measured: On day 2-3 of the first menstrual cycle post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start23 Jan 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Response to Ovulation InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Group of participants receiving PRP treatment Women presenting with POR, treated with autologous PRP intraovarian infusion in the mid-luteal phase of the menstrual cycle, undergoing a subsequent stimulated fresh Embryo Transfer-Intracytoplasmic Sperm Injection (ET-ICSI) cycle on the first menstrual cycle following PRP treatment. Control Group: Group of participants receiving standard management Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genesis Athens Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Sponsor
- Investigators
- Agni Pantou, M.D, Principal investigator, Genesis Athens Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181748
- Sponsor's protocol ID
- GenesisAC
- Acronym
- PRPPOR
- Status last verified
- Jul 2026
- First submitted
- 20 Dec 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be provided upon reasonable request, following authorization by the Scientific and Ethical Board of Genesis Athens Clinic