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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorBeijing Obstetrics and Gynecology Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Injectable Platelet-Rich Fibrin

    Biological/Vaccine

    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.

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Injectable Platelet-Rich FibrinExperimental treatment 1 intervention
Group B: Sodium HyaluronateActive comparator 1 intervention

Trial outcomes

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%.

Time frame
From enrollment to the end of treatment at 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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