Clinical Study of i-PRF Intrauterine Perfusion for Endometrial Regeneration and Repair in Moderat… (NCT07536971) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study of i-PRF Intrauterine Perfusion for Endometrial Regeneration and Repair in Moderate to Severe Intrauterine Adhesions
China200 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Pregnancy Rate
Timeframe: From enrollment to the end of treatment at 2 years