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NCT07536971
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Clinical Study of i-PRF Intrauterine Perfusion for Endometrial Regeneration and Repair in Moderate to Severe Intrauterine Adhesions

Sponsor: Beijing Obstetrics and Gynecology Hospital

View on ClinicalTrials.gov

Summary

Intrauterine adhesions (IUA) caused by endometrial basal layer injury can lead to reduced menstrual flow, infertility, recurrent pregnancy loss, and poor reproductive outcomes. Hysteroscopic adhesiolysis with uterine cavity reconstruction is the standard treatment, but women with moderate to severe IUA still have high rates of re-adhesion and unsatisfactory endometrial repair after surgery. Injectable platelet-rich fibrin (i-PRF) is an autologous blood-derived biologic material that can be prepared at the bedside. Compared with conventional platelet-rich plasma, i-PRF may provide a more sustained release of growth factors and form a fibrin scaffold after intrauterine administration, which may help protect the wound surface, support endometrial regeneration, improve blood perfusion, and reduce postoperative re-adhesion. This prospective randomized controlled study will evaluate the efficacy and safety of intrauterine i-PRF perfusion in women with moderate to severe IUA after hysteroscopic adhesiolysis. Participants will be assigned to receive either i-PRF intrauterine perfusion or sodium hyaluronate intrauterine treatment after surgery. The study will compare postoperative uterine cavity recovery, endometrial thickness and blood flow, clinical pregnancy outcomes, and safety events. The goal is to determine whether i-PRF can improve endometrial regeneration and reproductive outcomes and provide evidence for an optimized postoperative treatment strategy for moderate to severe IUA.

Official title: A Randomized Controlled Clinical Study on the Effect of i-PRF Intrauterine Perfusion on Endometrial Regeneration and Repair in Patients With Moderate to Severe Intrauterine Adhesions

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-05-01

Completion Date

2029-06-30

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

Injectable Platelet-Rich Fibrin

Autologous injectable platelet-rich fibrin (i-PRF) prepared from the participant's peripheral venous blood at the bedside. A total of 3 mL will be perfused into the uterine cavity through the uterine cavity balloon drug channel immediately after hysteroscopic adhesiolysis and again on postoperative day 5.

DRUG

Sodium Hyaluronate

A total of 3 mL of sodium hyaluronate will be administered into the uterine cavity through the uterine cavity balloon drug channel immediately after hysteroscopic adhesiolysis.

Locations (1)

Beijing obstetrics and gynecology hospital

Beijing, China