RecruitingPhase 2Phase 3NCT05181748

Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

Investigating the Efficiency of Autologous Platelet Rich Plasma Intraovarian Infusion on Improving Ovarian Functionality in Poor Ovarian Response Patients


Sponsor

Genesis Athens Clinic

Enrollment

100 participants

Start Date

Jan 23, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 35 YearsMax Age: 47 Years

Inclusion Criteria6

  • 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 Criteria14

  • 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

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Interventions

BIOLOGICALAutologous 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 approximately 1.000.000 platelets/µL. The technique of PRP intraovarian infusion resembles the transvaginal paracentesis performed during the oocyte pick-up procedure. Briefly, both ovaries are visualized via transvaginal ultrasound monitoring, and they are intramedullary injected on multiple sites using a 17-gauge single lumen needle, with the patient under inhaled minimal sedation.


Locations(1)

Genesis Athens Clinic

Athens, Attica, Greece

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NCT05181748


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