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

Starting soon · Not applicable

Conditions studied: Intrauterine Adhesions

In brief

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.

Key facts

Study ID

NCT07536971

Run by

Beijing Obstetrics and Gynecology Hospital

People needed

200

Starts

2026-05-01

Expected to finish

2029-06-30

Last updated by the study team

2026-04-17

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female participants aged 20 to 40 years
• Moderate to severe intrauterine adhesions caused by endometrial injury, defined according to the Chinese diagnostic and grading standard (CSGE score >=9)
• Strong desire for fertility
• Normal ovarian function
• Planned to undergo hysteroscopic adhesiolysis with uterine cavity reconstruction
• Willing to comply with follow-up requirements
• Able and willing to provide written informed consent

You may not qualify if…

• Contraindications to hysteroscopic uterine cavity reconstruction surgery
• Use of aspirin or other antiplatelet nonsteroidal anti-inflammatory drugs within 10 days before or after surgery
• Hematologic disorders, including platelet dysfunction, severe anemia, or blood-borne infection
• Contraindications to postoperative estrogen or progestin treatment
• Other uterine diseases, such as congenital uterine malformation, adenomyosis, or submucosal fibroids
• Other causes of infertility, including endocrine abnormalities, polycystic ovary syndrome, diminished ovarian reserve, premature ovarian insufficiency, or premature ovarian failure
• History of pelvic malignancy or pelvic radiotherapy
• Severe hepatic or renal dysfunction
• Contraindications to pregnancy
• Male partner-related infertility factors, such as abnormal semen findings

Where it is running

• Beijing obstetrics and gynecology hospital — Beijing, China

Full record on ClinicalTrials.gov

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