drugset / Trial / NCT07162961

Nintedanib for Improving Reproductive Outcomes in Adenomyosis

NCT07162961

Phase 3 Not yet recruiting 328 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study aims to evaluate the effectiveness and safety of nintedanib, an antifibrotic drug, in improving live birth rates for infertile women with adenomyosis who have frozen embryos. Based on promising animal data showing reduced uterine fibrosis, participants will be randomized to receive either standard progesterone therapy plus nintedanib or progesterone therapy alone for three months before undergoing a frozen embryo transfer cycle.

Timeline

Start
2025-09-01
Primary completion
2026-06-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nintedanib Small molecule 100 mg Oral
Background Progesterone Other / unclassified

Indications