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NCT Number: NCT04031456

Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

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Key information

Conditions

Menopause, Premature Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Menopausal Syndrome Menopause Related Conditions Ovarian Diseases Ovarian Failure, Premature Premature Ovarian Failure Primary Ovarian Insufficiency Urogenital Diseases

Age range

25 year–39 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

Konstantinos Pantos, MD, PhD

PRINCIPAL_INVESTIGATOR

Mara Simopoulou, PhD

CONTACT

About this study

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. 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 restoring ovarian tissue functionality in POI patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age < 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels >25 IU/L recorded on two occasions >4 weeks apart
  • Normal Karyotype: 46, XX
  • 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
  • AMH > 8 pmol/L
  • 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

Autologous Platelet Rich Plasma

Biological

Autologous PRP intra ovarian infusion

Other names: PRP, Platelet Rich Plasma

Placebo-Platelet Free Plasma

Biological

Autologous PFP intra ovarian infusion

Other names: PFP

Primary outcomes

  1. Restoration of menstrual cycle

    Time frame: Three months

    Regular menstrual cycle

  2. Serum FSH levels

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

    Serum FSH levels evaluated monthly for three consecutive months

Secondary outcomes

  1. Serum AMH levels

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

    Serum ΑΜΗ levels evaluated monthly for three consecutive months

  2. Serum LH levels

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

    Serum LH levels evaluated monthly for three consecutive months

  3. Serum Estradiol levels

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

    Serum estradiol levels evaluated monthly for three consecutive months

  4. Serum Progesteron levels

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

    Serum progesterone levels evaluated monthly for three consecutive months

  5. Antral Follicle Count (AFC)

    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

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 Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients

Acronym: PRP

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Jul 24, 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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