Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women

Genesis Athens Clinic

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Amenorrhea; Menopause; Anovulatory Infertility; Infertility, Female

Treatments: Biological: Autologous PFP intra ovarian infusion; Biological: Autologous PRP intra ovarian infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03916978

PRP - Menopausal women

Details and patient eligibility

About

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

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 menopausal 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 restoring ovarian tissue functionality in menopausal women.

Enrollment: 100 estimated patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 45-55 years old
• Amenorrhea for at least 12 months
• 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
• Previous POI diagnosis
• Abnormal karyotype
• Endometriosis
• Adenomyosis
• Fibroids and adhesions
• Infections in reproductive system
• Current or previous diagnosis of reproductive system cancer
• 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

---

100 participants in 2 patient groups, including a placebo group

Participants receiving PRP treatment

Experimental group

Description:

Menopausal women minimum 45 years of age, receiving ovarian PRP treatment.

Treatment:

Biological: Autologous PRP intra ovarian infusion

Control Group: Participants receiving Platelet Free Plasma

Placebo Comparator group

Description:

Women in menopause, 45-55 years old, treated with autologous PFP intra ovarian infusion.

Treatment:

Biological: Autologous PFP intra ovarian infusion