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NCT Number: NCT03937661

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

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).

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Key information

Conditions

Ovary; Anomaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

35 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Genesis AC

Athens, 15232, Greece

Location status: Recruiting

Location contact

Agni Pantou, MD

PRINCIPAL_INVESTIGATOR

Agni Pantou, MD, PhD Candidate

CONTACT

[email protected]

Konstantinos Pantos, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and fresh ET-ICSI cycles' performance in regard to patients presenting with POR. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on improving ovarian tissue functionality in POR patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, acupuncture, and botanotherapy, 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 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

Treatment and study plan

PRP

Biological

Autologous PRP intra ovarian infusion

Placebo

Biological

Autologous PFP intra ovarian infusion

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 34-36 hours following hCG administration

    Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period

  2. AMH levels

    Time frame: Follow-up period of three months entailing monthly evaluation

    Serum AMH levels evaluated monthly for three consecutive months

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 6-7 weeks following last menstruation

    Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period

  2. Antral Follicle Count

    Time frame: Follow-up period of three months entailing monthly evaluation

    AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months

Study contacts

Contact information is provided by the study sponsor or research team.

Agni Pantou, MD, PhD Candidate

CONTACT

[email protected]

+306974447702

Mara Simopoulou, PhD

CONTACT

[email protected]

+306979234100

Sponsors and collaborators

Lead sponsor

Genesis Athens Clinic

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

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

Acronym: PRP

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
May 6, 2019
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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