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NOT YET RECRUITING
NCT07162961
PHASE3

Nintedanib for Improving Reproductive Outcomes in Adenomyosis

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - 38 Years

Study Type

INTERVENTIONAL

Enrollment

328

Start Date

2025-09-01

Completion Date

2027-06-30

Last Updated

2025-09-09

Healthy Volunteers

No

Interventions

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