Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders

Infertility, Female Clinical Trial

— PRP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03937661
• Other study ID #: PRP - poor responders
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 6, 2019
• Est. completion date: August 30, 2025

Study information

• Verified date: February 2023
• Source: Genesis Athens Clinic
• Contact: Mara Simopoulou, PhD
• Phone: +306979234100
• Email: marasimopoulou[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2025
• Est. primary completion date: January 30, 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)
• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Ovary; Anomaly

Intervention

Biological:
• PRP
Autologous PRP intra ovarian infusion
• Placebo
Autologous PFP intra ovarian infusion

Locations

Country	Name	City	State
Greece	Genesis AC	Athens

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 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
Primary	AMH levels	Serum AMH levels evaluated monthly for three consecutive months	Follow-up period of three months entailing monthly evaluation
Secondary	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
Secondary	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