Recruiting

PRP

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07920900

Conditions

Female Sexual Dysfunction

Sexual Dysfunction

Physiological

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Autologous Platelet-Rich Plasma (PRP) Injection

Sterile saline injection

Study Details

Brief summary:

This randomized, single-blinded, sham-controlled trial evaluates whether a single injection of autologous platelet-rich plasma (PRP) into the distal anterior vaginal wall improves sexual function in women with sexual dysfunction. Sixty participants with a Female Sexual Function Index (FSFI) total score of 26.5 or lower are randomized 1:1 to PRP injection or sterile saline injection. Sexual function, sexual distress, global impression of change, and urinary incontinence symptoms are assessed at baseline, 6 weeks, and 6 months after injection.

Conditions

Female Sexual Dysfunction

Sexual Dysfunction

Physiological

Study ID

NCT07920900

Start date

Aug 27, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female, 18 years of age or older, presenting with sexual dysfunction
  • FSFI total score ≤ 26.5
  • English speaking and literate

Exclusion Criteria:

  • Unwilling or unable to provide informed consent
  • Pregnant or less than 12 weeks postpartum
  • Known history of bleeding disorder

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving a PRP Injection

Participants will receive a single injection of 4-5cc autologous platelet-rich plasma into the distal anterior vaginal wall after blood draw.

sham comparator: Participants receiving Saline Injection

Participants will receive a single injection of 4-5cc sterile saline into the distal anterior vaginal wall after blood draw (blood sample will be discarded).

Interventions

Autologous Platelet-Rich Plasma (PRP) Injection

Whole blood draw of 40 mL is processed by double-spin centrifugation; 4 cc PRP is injected with a 25-guage needle just deep to the epithelium of the distal anterior vaginal wall, about 3 cm from the urethral meatus, after topical lidocaine.

Sterile saline injection

4-5cc sterile saline injected at the same location, depth, and technique as the PRP arm, following a blood draw.

Primary outcome measure

  • Change in total score of The Female Sexual Function Index (FSFI) [ Time Frame: Baseline, 6 weeks, and 6 months after injection. ]

Central Contacts and Locations

Central contacts

Yara Sifri, MD

978-273-1786vaginalprp@gmail.com

Locations

The Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Yara Sifri, MD

978-273-1786vaginalprp@gmail.com

Principal Investigator:

Charles Ascher-Walsh

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Nov 6, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.