Autologous Platelet Rich Plasma (PRP) Intra Ovarian Infusion in Perimenopausal Women

Genesis Athens Clinic

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Perimenopausal Disorder; Menstrual Cycle Abnormal; Infertility, Female

Treatments: Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion; Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03951194

PRP- Perimenopause

Details and patient eligibility

About

Autologous PRP intra ovarian infusion may improve ovarian response and women's hormonal profile and may promote folliculogenesis in perimenopausal women.

Full description

This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and hormonal profile of perimenopausal women. 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 perimenopausal women.

Enrollment: 100 estimated patients

Sex: Female

Ages: 40 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels.
• 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
• 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
• Previous POI diagnosis -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:

Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.

Treatment:

Biological: Autologous Platelet Rich Plasma (PRP) intra ovarian infusion

Participants receiving Platelet Free Plasma (PFP)

Placebo Comparator group

Description:

Perimenopausal women, 40-50 years of age, treated with autologous PRP intra ovarian infusion.

Treatment:

Other: Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion