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NCT Number: NCT05181748

Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

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.

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Key information

Age range

35 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Genesis Athens Clinic

Athens, Attica, 15232, Greece

Location status: Recruiting

Location contact

Agni Pantou, M.D

CONTACT

[email protected]

+306974447702

Agni Pantou, M.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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/adjuvant treatment including hormone replacement and acupuncture, for at least three months prior to recruitment.
  • Willing to comply with study requirements

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)
  • BMI>30 kg/m2 or BMI<18.5 kg/m2
  • Systematic autoimmune disorders

Treatment and study plan

Autologous Platelet Rich Plasma

Biological

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.

Other names: PRP

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 34-36 hours following ovulation triggering

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

  2. Anti-Müllerian Hormone Levels (AMH)

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

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

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 6-7 weeks following last menstruation

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

  2. Antral Follicle Count (AFC)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Agni Pantou, M.D

CONTACT

[email protected]

+306974447702

Konstantinos Pantos, M.D., Ph.D

CONTACT

[email protected]

+302106894326

Sponsors and collaborators

Lead sponsor

Genesis Athens Clinic

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients

Acronym: PRPPOR

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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