Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

Phase 2

Recruiting

• Conditions: Ovarian Insufficiency; Ovary; Anomaly; Poor Response to Ovulation Induction; Infertility, Female; Ovarian Failure; Reproductive Sterility
• Interventions: Biological: Autologous platelet rich plasma

• Registration Number: NCT05181748
• Lead Sponsor: Genesis Athens Clinic

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.

Study Timeline

• Study Start: 2019-01-23
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2022-01-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Group of participants receiving PRP treatment	Autologous platelet rich plasma	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

Primary Outcome Measures

Name	Time	Method
Anti-Müllerian Hormone Levels (AMH)	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
Number of oocytes retrieved	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

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6-7 weeks following last menstruation	Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the first menstrual cycle after intervention
Antral Follicle Count (AFC)	On day 2-3 of the first menstrual cycle post intervention	Antral Follicle Count (AFC) evaluated in the first menstrual cycle following intervention

Trial Locations

Locations (1)

Genesis Athens Clinic; 🇬🇷 Athens, Attica, Greece