Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous platelet rich plasma.
- Who it may be relevant to
- Registry conditions: Poor Response to Ovulation Induction, Infertility, Female, Ovarian Insufficiency, Ovarian Failure. Basic parameters: 35 years — 47 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients
Overview
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.
Interventions
- 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 a
Primary outcome measures
- Number of oocytes retrieved [Time frame: 34-36 hours following ovulation triggering]
- Anti-Müllerian Hormone Levels (AMH) [Time frame: On day 2-3 of the first menstrual cycle post intervention]
Secondary outcome measures (2)
- Clinical pregnancy rate [Time frame: 6-7 weeks following last menstruation]
- Antral Follicle Count (AFC) [Time frame: On day 2-3 of the first menstrual cycle post intervention]
Eligibility criteria
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Greece · 1 center
- Genesis Athens Clinic — Athens
Identifiers
NCT: NCT05181748 · GenesisAC