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

Primary Purpose

Poor Response to Ovulation Induction, Infertility, Female, Ovarian Insufficiency

Status
Recruiting
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Autologous platelet rich plasma
Sponsored by
Genesis Athens Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Poor Response to Ovulation Induction focused on measuring Autologous platelet rich plasma intraovarian infusion, Assisted reproduction, PRP, In vitro fertilization, Ovarian functionality improvement

Eligibility Criteria

35 Years - 47 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Genesis Athens ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: Group of participants receiving PRP treatment

Control Group: Group of participants receiving standard protocol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical pregnancy rate
Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the first menstrual cycle after intervention
Antral Follicle Count (AFC)
Antral Follicle Count (AFC) evaluated in the first menstrual cycle following intervention

Full Information

First Posted
December 20, 2021
Last Updated
September 24, 2023
Sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05181748
Brief Title
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Acronym
PRPPOR
Official Title
Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genesis Athens Clinic
Collaborators
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Group of participants receiving PRP treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group: Group of participants receiving standard protocol
Arm Type
No Intervention
Arm Description
Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle
Intervention Type
Biological
Intervention Name(s)
Autologous platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Description
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
Title
Anti-Müllerian Hormone Levels (AMH)
Description
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 Outcome Measure Information:
Title
Clinical pregnancy rate
Description
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
Title
Antral Follicle Count (AFC)
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
47 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agni Pantou, M.D
Phone
+306974447702
Email
agni.pantou@genesisathens.gr
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos Pantos, M.D., Ph.D
Phone
+302106894326
Email
info@pantos.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agni Pantou, M.D
Organizational Affiliation
Genesis Athens Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesis Athens Clinic
City
Athens
State/Province
Attica
ZIP/Postal Code
15232
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agni Pantou, M.D
Phone
+306974447702
Email
agni.pantou@genesisathens.gr
First Name & Middle Initial & Last Name & Degree
Agni Pantou, M.D

12. IPD Sharing Statement

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

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Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

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