Adenomyosis of UterusPhase 3NCT07162961
Nintedanib for Improving Reproductive Outcomes in Adenomyosis
A Phase 3 study testing Nintedanib and Progesterone in people with Adenomyosis of Uterus, run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Adenomyosis of Uterus
- What is being tested?
- Nintedanib and Progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Single-center, Randomized, Prospective, Controlled Clinical Study on the Efficacy of Nintedanib in Improving Reproductive Outcomes in Women With Adenomyosis
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
- Being tested
- Nintedanib, Progesterone
- Keywords
- Adenomyosis, nintedanib
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NintedanibDrug
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.
ProgesteroneDrug
For control group
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib + Progesterone | Experimental | Nintedanib Esylate Soft Capsules (100mg). Oral, twice daily (BID) for 3 months+ Progesterone therapy (as per standard practice for 3 months). Receives: Drug: Nintedanib; Drug: Progesterone |
| Progesterone Only | Active comparator | Progesterone therapy (as per standard practice for 3 months). Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Defined as the delivery of any live infant after 24 weeks of gestation. Calculated as: (Number of subjects with live birth / Number of subjects undergoing embryo transfer) * 100%.
Measured: Up to approximately 9-12 months after embryo transfer (considering gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomyosis of UterusStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162961
- Sponsor's protocol ID
- New IVF
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This involves the patient's informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Prospective, Controlled Clinical Study on the Efficacy of Nintedanib in Improving Reproductive Outcomes in Women With Adenomyosis
- ClinicalTrials.gov ID
- NCT07162961
- Acronym / sponsor ID
- New IVF
- Conditions
- Adenomyosis of Uterus
- Keywords
- Adenomyosis, nintedanib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib + Progesterone | Experimental | Drug: Nintedanib, Drug: ProgesteroneNintedanib Esylate Soft Capsules (100mg). Oral, twice daily (BID) for 3 months+ Progesterone therapy (as per standard practice for 3 months). |
| Progesterone Only | Active comparator | Drug: ProgesteroneProgesterone therapy (as per standard practice for 3 months). |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NintedanibParticipants 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 | Nintedanib + Progesterone |
| ProgesteroneFor control group | Drug | Nintedanib + Progesterone, Progesterone Only |
Primary outcome
live birth rate
Time frame: Up to approximately 9-12 months after embryo transfer (considering gestation)
Defined as the delivery of any live infant after 24 weeks of gestation. Calculated as: (Number of subjects with live birth / Number of subjects undergoing embryo transfer) * 100%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No. This involves the patient's informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nintedanib and Progesterone in people with Adenomyosis of Uterus, run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: Up to approximately 9-12 months after embryo transfer (considering gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.