Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

Infertility, Female Clinical Trial

— PRPPOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05181748
• Other study ID #: GenesisAC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 23, 2019
• Est. completion date: January 31, 2026

Study information

• Verified date: September 2023
• Source: Genesis Athens Clinic
• Contact: Agni Pantou, M.D
• Phone: +306974447702
• Email: agni.pantou[@]genesisathens.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Greece	Genesis Athens Clinic	Athens	Attica

Sponsors (2)

Lead Sponsor	Collaborator
Genesis Athens Clinic	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	34-36 hours following ovulation triggering
Primary	Anti-Müllerian Hormone Levels (AMH)	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	Clinical pregnancy rate	Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the first menstrual cycle after intervention	6-7 weeks following last menstruation
Secondary	Antral Follicle Count (AFC)	Antral Follicle Count (AFC) evaluated in the first menstrual cycle following intervention	On day 2-3 of the first menstrual cycle post intervention