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

NCT07536971 | Not Yet Recruiting DMC

• 1 other identifier: IPRF-IUA-RCT-2026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrauterine Adhesions

Keywords

Intrauterine Adhesions; TCRA; Platelet-Rich Plasma; RCT

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  Clinical pregnancy refers to the detection of a gestational sac inside the uterus by ultrasound after natural conception or assisted reproduction. Clinical pregnancy rate = (number of clinical pregnancies / total number of participants in the study or control group) × 100%.

  From enrollment to the end of treatment at 2 years

Study Arms (2)

Injectable Platelet-Rich Fibrin

EXPERIMENTAL

Participants will undergo standard hysteroscopic adhesiolysis with uterine cavity reconstruction and placement of a uterine cavity balloon. After surgery, 3 mL of freshly prepared autologous injectable platelet-rich fibrin (i-PRF) will be perfused into the uterine cavity through the balloon drug channel immediately after surgery and again on postoperative day 5. Participants will also receive postoperative artificial cycle therapy and prophylactic antibiotics according to the study protocol.

Biological: Injectable Platelet-Rich Fibrin

Sodium Hyaluronate

ACTIVE COMPARATOR

Participants will undergo standard hysteroscopic adhesiolysis with uterine cavity reconstruction and placement of a uterine cavity balloon. After surgery, 3 mL of sodium hyaluronate will be administered into the uterine cavity through the balloon drug channel immediately after surgery. Participants will also receive postoperative artificial cycle therapy and prophylactic antibiotics according to the study protocol.

Drug: Sodium Hyaluronate

Interventions

Injectable Platelet-Rich Fibrin BIOLOGICAL

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.

Also known as: i-PRF

Injectable Platelet-Rich Fibrin

Sodium Hyaluronate DRUG

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.

Sodium Hyaluronate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Beijing Obstetrics and Gynecology Hospital: lead

Study Sites (1)

Beijing obstetrics and gynecology hospital

Beijing, China

Location

MeSH Terms

Conditions

Gynatresia

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Fang Chen, Dr.

CONTACT

+86 13581582372; 24713144@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. No masking procedures are described in the protocol. Randomization will be implemented using a computer-generated random number table, and allocation concealment will be maintained with sealed opaque envelopes until group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. The experimental group will receive intrauterine i-PRF perfusion after hysteroscopic adhesiolysis, and the control group will receive sodium hyaluronate intrauterine treatment after surgery. Participants remain in their assigned group throughout the study for efficacy and safety follow-up.

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)