An interventional study of Injectable Platelet-Rich Fibrin and Sodium Hyaluronate in Intrauterine Adhesions, sponsored by Beijing Obstetrics and Gynecology Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Beijing Obstetrics and Gynecology Hospital · Not applicable, Interventional, and Treatment
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.
Intrauterine adhesions (IUA) are caused by injury to the endometrial basal layer, usually after intrauterine procedures or infection, and may result in hypomenorrhea, amenorrhea, infertility, recurrent miscarriage, and impaired reproductive function. Hysteroscopic adhesiolysis with uterine cavity reconstruction is the standard treatment. However, for women with moderate to severe IUA, postoperative endometrial regeneration remains inadequate, re-adhesion is common, and pregnancy outcomes remain suboptimal.
Autologous platelet concentrates have shown potential in tissue repair. Previous work by the study team suggested that intrauterine platelet-rich plasma (PRP) after transcervical resection of adhesions may reduce re-adhesion and increase endometrial thickness, but the effect may be limited by rapid biologic activity loss. Injectable platelet-rich fibrin (i-PRF), a second-generation autologous platelet concentrate, remains in liquid form before administration and then rapidly forms a fibrin gel in the uterine cavity. This material may act as both a physical barrier and a biologically active scaffold, while allowing sustained release of growth factors that support tissue repair, angiogenesis, and modulation of local inflammation.
This study is a prospective randomized controlled clinical trial conducted at Beijing Obstetrics and Gynecology Hospital, Capital Medical University. The objective is to evaluate the efficacy and safety of intrauterine i-PRF perfusion after hysteroscopic adhesiolysis in women with moderate to severe IUA and to compare it with sodium hyaluronate intrauterine treatment.
Women of reproductive age with moderate to severe IUA, defined according to the Chinese diagnostic and grading standard (CSGE score >=9), who have a strong fertility desire and plan to undergo hysteroscopic adhesiolysis will be screened for enrollment. Participants who meet all eligibility criteria and provide informed consent will be randomly assigned in a 1:1 ratio to one of 2 groups.
All participants will undergo standard hysteroscopic adhesiolysis with uterine cavity reconstruction and placement of a uterine cavity balloon. In the experimental group, 3 mL of freshly prepared autologous i-PRF will be perfused into the uterine cavity through the balloon drug channel immediately after surgery and again on postoperative day 5. In the control group, 3 mL of sodium hyaluronate will be administered through the same route immediately after surgery. Both groups will also receive postoperative artificial cycle treatment and prophylactic antibiotics according to the study protocol.
The study will assess both efficacy and safety. Efficacy endpoints include postoperative uterine cavity morphology and re-adhesion rate based on second-look hysteroscopy after 2 menstrual cycles, endometrial thickness, endometrial volume, and endometrial blood flow assessed by transvaginal ultrasound during the implantation window, and clinical pregnancy outcomes during follow-up. Safety assessments include body temperature, abdominal pain, vaginal discharge, blood routine testing, coagulation-related events, and monitoring for infection or thrombotic complications.
Participants will be followed during hospitalization, within 1 month after discharge, after 2 menstrual cycles for hysteroscopic and ultrasound reassessment, and again at 6, 12, and 24 months for reproductive outcomes. The planned sample size is 200 participants, with 100 in each group.
This study aims to determine whether intrauterine i-PRF perfusion can improve endometrial regeneration and repair, reduce postoperative re-adhesion, improve endometrial receptivity and pregnancy outcomes, and provide clinical evidence for a practical and safe regenerative treatment strategy for moderate to severe IUA.
99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 87 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →Beijing Obstetrics and Gynecology Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2028, 31 months later.
Of 46 interventional studies with no phase under Gynatresia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 77. This study's planned 31 months is above that.
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Beijing Obstetrics and Gynecology Hospital