Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders (PRPPOR)

September 24, 2023 updated by: Genesis Athens Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Konstantinos Pantos, M.D., Ph.D
  • Phone Number: +302106894326
  • Email: info@pantos.gr

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 15232
        • Recruiting
        • Genesis Athens Clinic
        • Contact:
        • Principal Investigator:
          • Agni Pantou, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 47 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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/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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
No Intervention: Control Group: Group of participants receiving standard protocol
Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
34-36 hours following ovulation triggering
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
On day 2-3 of the first menstrual cycle post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-7 weeks following last menstruation
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
On day 2-3 of the first menstrual cycle post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genesis Athens Clinic

Collaborators

National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: Agni Pantou, M.D, Genesis Athens Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenesisAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will be provided upon reasonable request, following authorization by the Scientific and Ethical Board of Genesis Athens Clinic

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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