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COMPLETED
NCT07863739
NA

CO₂ Laser With or Without Platelet-Rich Plasma for Genitourinary Syndrome of Menopause

Sponsor: National and Kapodistrian University of Athens

View on ClinicalTrials.gov

Summary

This study evaluated whether adding platelet-rich plasma (PRP) to fractional CO₂ laser treatment provides additional benefit for postmenopausal women with genitourinary syndrome of menopause (GSM). Participants received either fractional CO₂ laser treatment alone or fractional CO₂ laser combined with PRP injections. Both groups received three treatment sessions at 4-6-week intervals. The main outcome was the change in vaginal dryness after treatment. Other outcomes included vaginal symptoms, sexual function, quality of life, and measures of vaginal health. The study also evaluated the safety and tolerability of both treatments.

Official title: Fractional CO₂ Laser Versus Combined CO₂ Laser and Platelet-Rich Plasma for the Management of Genitourinary Syndrome of Menopause: A Prospective Study.

Key Details

Gender

FEMALE

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-06-01

Completion Date

2025-04-01

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DEVICE

Fractional CO₂ Laser

Fractional laser treatment was performed using the DEKA DUOGlide GYN system (DEKA M.E.L.A., Florence, Italy), combining CO₂ (10,600 nm) and 1540 nm wavelengths. Three treatment sessions were performed at 4-6-week intervals.

BIOLOGICAL

Autologous Platelet-Rich Plasma (PRP)

Autologous PRP was prepared from 40 mL of peripheral blood using the OMNIPLEX Gyno kit, yielding approximately 3 mL of PRP with a platelet concentration approximately nine times baseline. PRP was injected into predefined vaginal sites immediately after each laser treatment.

Locations (1)

Alexandra General Hospital

Athens, Greece