Nintedanib for Improving Reproductive Outcomes in Adenomyosis

NCT07162961 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: New IVF
• Study Type: interventional
• Target: 328
• Locations: 0 countries
• Sites: N/A

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 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

Keywords

Adenomyosis; nintedanib

Outcome Measures

Primary Outcomes (1)

• 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%.

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

Study Arms (2)

Nintedanib + Progesterone

EXPERIMENTAL

Nintedanib Esylate Soft Capsules (100mg). Oral, twice daily (BID) for 3 months+ Progesterone therapy (as per standard practice for 3 months).

Drug: Nintedanib; Drug: Progesterone

Progesterone Only

ACTIVE COMPARATOR

Progesterone therapy (as per standard practice for 3 months).

Drug: Progesterone

Interventions

Nintedanib DRUG

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.

Nintedanib + Progesterone

Progesterone DRUG

For control group

Nintedanib + Progesterone; Progesterone Only

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Adenomyosis

Interventions

nintedanib; Progesterone

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Dean

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share