Status:
NOT_YET_RECRUITING
Nintedanib for Improving Reproductive Outcomes in Adenomyosis
Lead Sponsor:
Sun Yat-sen University
Conditions:
Adenomyosis of Uterus
Eligibility:
FEMALE
20-38 years
Phase:
PHASE3
Brief 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 promi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT07162961
Start Date
September 1 2025
End Date
June 30 2027
Last Update
September 9 2025
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