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

Genesis Athens Clinic

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Menopause Related Conditions; Menopausal Syndrome; Menopause, Premature; Ovarian Failure, Premature; Premature Ovarian Failure

Treatments: Biological: Placebo-Platelet Free Plasma; Biological: Autologous Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04031456

PRP- POI

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 25 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Participants receiving PRP treatment

Experimental group

Description:

Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion

Treatment:

Biological: Autologous Platelet Rich Plasma

Participants receiving Platelet Free Plasma (PFP) treatment

Placebo Comparator group

Description:

Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion

Treatment:

Biological: Placebo-Platelet Free Plasma