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Clinical Trial Summary

In moderate to severe cavity adhesions, the endometrial basal layer is more severely damaged and the regenerative capacity of the endometrium and glands is low. Even though hysteroscopic electrosurgery can roughly restore the cavity morphology, the postoperative recurrence rate is as high as 40%. Abnormal uterine cavity morphology and poor endometrial repair often lead to repeated cancellation of embryo transfer cycles in assisted reproduction treatment, and reduced clinical pregnancy rate, causing mental stress and financial burden to patients, which is one of the current problems in clinically assisted reproduction treatment. Nintedanib is a triple vascular kinase inhibitor that acts primarily on platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR) and has been approved by the FDA for the clinical treatment of idiopathic pulmonary fibrosis and systemic sclerosis. The investigator's preliminary animal study found that endometrial fibrosis was significantly reduced in mice with gastric feeding of nintedanib in uterine adhesion molds. This study aimed to clarify further the role of nintedanib in inhibiting endometrial fibrosis and its clinical application value.


Clinical Trial Description

The experiment will be divided into two groups based on the dose administered. After hysteroscopic surgery, one group will be given Nedanib 100mg bid orally for 15 days and the other group will be given Nedanib 150mg bid orally for 15 days. Hysteroscopic AFS scores and endometrial tissues before and after treatment will be collected for molecular biology experiments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05635071
Study type Interventional
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date December 1, 2023
Completion date December 30, 2024