RecruitingPhase 2Phase 3NCT03937661

Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders

Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders


Sponsor

Genesis Athens Clinic

Enrollment

100 participants

Start Date

May 6, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).


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, acupuncture, and botanotherapy, for at least three months prior to recruitment.
  • Willing to comply with study requirements

Exclusion Criteria15

  • 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 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

BIOLOGICALPRP

Autologous PRP intra ovarian infusion

BIOLOGICALPlacebo

Autologous PFP intra ovarian infusion


Locations(1)

Genesis AC

Athens, Greece

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NCT03937661


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