About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Injectable Platelet-Rich Fibrin
Biological/VaccineAutologous 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.
Sodium Hyaluronate
DrugA 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.
Treatment groups
Trial outcomes
Primary outcomes
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%.
Sponsors and contacts
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