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Recruiting NCT04031456

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

Phase II / Phase III Interventional Menopause, Premature Menopause Related Conditions Menopausal Syndrome Premature Ovarian Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Platelet Rich Plasma, Placebo-Platelet Free Plasma.
Who it may be relevant to
Registry conditions: Menopause, Premature, Menopause Related Conditions, Menopausal Syndrome, Premature Ovarian Failure. Basic parameters: 25 years — 39 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

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.

Interventions

  • Biological Autologous Platelet Rich Plasma
    Autologous PRP intra ovarian infusion
  • Biological Placebo-Platelet Free Plasma
    Autologous PFP intra ovarian infusion

Primary outcome measures

  • Restoration of menstrual cycle [Time frame: Three months]
  • Serum FSH levels [Time frame: Follow-up period of three months entailing monthly evaluation]
Secondary outcome measures (5)
  • Serum AMH levels [Time frame: Follow-up period of three months entailing monthly evaluation]
  • Serum LH levels [Time frame: Follow-up period of three months entailing monthly evaluation]
  • Serum Estradiol levels [Time frame: Follow-up period of three months entailing monthly evaluation]
  • Serum Progesteron levels [Time frame: Follow-up period of three months entailing monthly evaluation]
  • Antral Follicle Count (AFC) [Time frame: Follow-up period of three months entailing monthly evaluation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Greece · 1 center
  • Genesis AC — Athens

Identifiers

NCT: NCT04031456 · PRP- POI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗