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

Genesis Athens Clinic

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Biological: Autologous platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05181748

GenesisAC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 35 to 47 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental: Group of participants receiving PRP treatment

Experimental group

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

Treatment:

Biological: Autologous platelet rich plasma

Control Group: Group of participants receiving standard protocol

No Intervention group

Description:

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