Not Yet RecruitingPhase 3

Nintedanib for Improving Reproductive Outcomes in Adenomyosis

328 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range

20 Years – 38 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Aged 20-38, diagnosed with primary or secondary infertility; with at least one vitrified high-quality blastocyst (grading ≥4BB). Diagnosed with adenomyosis within the last 3 months by MRI or transvaginal ultrasound, meeting the criteria of the Chinese Expert Consensus on Diagnosis and Treatment of Adenomyosis. Body Mass Index (BMI) between 18-27 kg/m². Regular menstrual cycles, no amenorrhea or severe dysfunctional uterine bleeding. Normal ovarian reserve (AMH \> 1 ng/mL or AFC ≥ 5 per ovary), not currently receiving ovarian suppression therapy. Signed informed consent, able to understand and voluntarily participate, and willing not to participate in other clinical trials during the study period. Exclusion Criteria: Uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/bicornuate/arcuate uterus, unremoved hydrosalpinx, endometrial polyp, submucosal myoma, or intramural myoma distorting the endometrial cavity). History of GnRH agonist injection within 3 months prior to embryo transfer. Unexplained abnormal vaginal bleeding. Known active pelvic inflammatory disease. Known genital malformation unsuitable for pregnancy. Abnormal cervical cytology (TCT) results within 1 year before screening. Severe impairment of liver or kidney function, heart disease, or hypertension. Known history of thrombophlebitis or thromboembolic disease. Any known clinically significant systemic disease (e.g., diabetes, tuberculosis). Known histor…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

live birth rate

Timeframe: Up to approximately 9-12 months after embryo transfer (considering gestation)

Trial details

NCT IDNCT07162961

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Adenomyosis of Uterus trials