Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders (PRP)

Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders

Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female; Ovary; Anomaly
• Intervention / Treatment: Biological: PRP; Biological: Placebo

Detailed Description

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and fresh ET-ICSI cycles' performance in regard to patients presenting with POR. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on improving ovarian tissue functionality in POR patients.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 15232
    • Recruiting
    • Genesis AC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 47 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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, acupuncture, and botanotherapy, 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 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group of participants receiving PRP treatment; Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period.	Biological: PRP; Autologous PRP intra ovarian infusion
Placebo Comparator: Control Group: participants receiving Platelet Free Plasma; Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period	Biological: Placebo; Autologous PFP intra ovarian infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oocytes retrieved	Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period	34-36 hours following hCG administration
AMH levels	Serum AMH levels evaluated monthly for three consecutive months	Follow-up period of three months entailing monthly evaluation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period	6-7 weeks following last menstruation
Antral Follicle Count	AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months	Follow-up period of three months entailing monthly evaluation

Collaborators and Investigators

• Sponsor: Genesis Athens Clinic
• Collaborators: National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Anticipated): January 30, 2025
• Study Completion (Anticipated): August 30, 2025

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: PRP - poor responders

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No