Could a fibrosis drug help women with adenomyosis get pregnant?
NCT ID NCT07162961
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether adding nintedanib, a drug that reduces scarring, to standard progesterone therapy can improve live birth rates in infertile women with adenomyosis. About 328 women aged 20-38 with frozen embryos will take either nintedanib plus progesterone or progesterone alone for three months before embryo transfer. The goal is to see if the combination leads to more successful pregnancies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nintedanib (an antifibrotic drug) plus progesterone
- What this could lead to
- If it works, this could offer a new treatment to improve pregnancy chances for women with adenomyosis who have frozen embryos.
- What could go wrong
- This is an early Phase 3 trial with no results yet. The drug may not improve live birth rates, and side effects from nintedanib are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 328 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 38 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 history of recurrent miscarriage. Chromosomal karyotype abnormality in either partner. Either partner has a genetic disease deemed unsuitable for childbearing per the "Maternal and Infant Health Care Law". Either partner has been exposed to teratogenic levels of radiation, toxins, or drugs. Any condition/combined surgery/medication/other clinically significant abnormal lab finding judged by the investigator to potentially affect trial results. Known refusal or inability to comply with the protocol requirements for any reason.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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