Clinical trial NCT05181748: Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Official title: Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Poor Response to Ovulation Induction
Infertility, Female
Ovarian Insufficiency
Ovarian Failure
Reproductive Sterility
Ovary; Anomaly
Keywords: Autologous platelet rich plasma intraovarian infusion
Assisted reproduction
PRP
In vitro fertilization
Ovarian functionality improvement
Lead sponsor: Genesis Athens Clinic
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2022-01-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Group of participants receiving PRP treatment Women presenting with POR, treated with autologous PRP intraovarian infusion in the mid-luteal phase of the menstrual cycle, undergoing a subsequent stimulated fresh Embryo Transfer-Intracytoplasmic Sperm Injection (ET-ICSI) cycle on the first menstrual cycle following PRP treatment.

Control Group: Group of participants receiving standard management Women presenting with POR undergoing a stimulated fresh ET-ICSI cycle
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 34-36 hours following ovulation triggering
measure: Anti-Müllerian Hormone Levels (AMH)
timeFrame: On day 2-3 of the first menstrual cycle post intervention
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6-7 weeks following last menstruation
measure: Antral Follicle Count (AFC)
timeFrame: On day 2-3 of the first menstrual cycle post intervention
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Genesis Athens Clinic
state: Attica
Study officials:
affiliation: Genesis Athens Clinic
name: Agni Pantou, M.D
role: PRINCIPAL_INVESTIGATOR
References: