NCT07162961

Nintedanib for Improving Reproductive Outcomes in Adenomyosis

A Single-center, Randomized, Prospective, Controlled Clinical Study on the Efficacy of Nintedanib in Improving Reproductive Outcomes in Women With Adenomyosis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 20 Years – 38 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenomyosis of Uterus

Interventions

Type	Name	Description
DRUG	Nintedanib	Participants will be randomly assigned to one of two groups: the Experimental Group will receive oral nintedanib (100 mg twice daily) plus progesterone therapy for three months; the Control Group will receive progesterone therapy only.
DRUG	Progesterone	For control group

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2025-09-09
• Last updated: 2025-09-09