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Could a fibrosis drug help women with adenomyosis get pregnant?

NCT ID NCT07162961

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 328 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

20 to 38 years

Sex

Female participants only

Healthy volunteers

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

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

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  1. The official record

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