Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
Study NCT ID:
NCT07162961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-09-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nintedanib for Improving Reproductive Outcomes in Adenomyosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D062788', 'term': 'Adenomyosis'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 328}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'live birth rate', 'timeFrame': 'Up to approximately 9-12 months after embryo transfer (considering gestation)', 'description': '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%.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adenomyosis', 'nintedanib'], 'conditions': ['Adenomyosis of Uterus']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged 20-38, diagnosed with primary or secondary infertility; with at least one vitrified high-quality blastocyst (grading ≥4BB).\n\nDiagnosed 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.\n\nBody Mass Index (BMI) between 18-27 kg/m².\n\nRegular menstrual cycles, no amenorrhea or severe dysfunctional uterine bleeding.\n\nNormal ovarian reserve (AMH \\> 1 ng/mL or AFC ≥ 5 per ovary), not currently receiving ovarian suppression therapy.\n\nSigned informed consent, able to understand and voluntarily participate, and willing not to participate in other clinical trials during the study period.\n\nExclusion Criteria:\n\nUterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/bicornuate/arcuate uterus, unremoved hydrosalpinx, endometrial polyp, submucosal myoma, or intramural myoma distorting the endometrial cavity).\n\nHistory of GnRH agonist injection within 3 months prior to embryo transfer.\n\nUnexplained abnormal vaginal bleeding.\n\nKnown active pelvic inflammatory disease.\n\nKnown genital malformation unsuitable for pregnancy.\n\nAbnormal cervical cytology (TCT) results within 1 year before screening.\n\nSevere impairment of liver or kidney function, heart disease, or hypertension.\n\nKnown history of thrombophlebitis or thromboembolic disease.\n\nAny known clinically significant systemic disease (e.g., diabetes, tuberculosis).\n\nKnown history of recurrent miscarriage.\n\nChromosomal karyotype abnormality in either partner.\n\nEither partner has a genetic disease deemed unsuitable for childbearing per the "Maternal and Infant Health Care Law".\n\nEither partner has been exposed to teratogenic levels of radiation, toxins, or drugs.\n\nAny condition/combined surgery/medication/other clinically significant abnormal lab finding judged by the investigator to potentially affect trial results.\n\nKnown refusal or inability to comply with the protocol requirements for any reason.'}, 'identificationModule': {'nctId': 'NCT07162961', 'briefTitle': 'Nintedanib for Improving Reproductive Outcomes in Adenomyosis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Single-center, Randomized, Prospective, Controlled Clinical Study on the Efficacy of Nintedanib in Improving Reproductive Outcomes in Women With Adenomyosis', 'orgStudyIdInfo': {'id': 'New IVF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nintedanib + Progesterone', 'description': 'Nintedanib Esylate Soft Capsules (100mg). Oral, twice daily (BID) for 3 months+ Progesterone therapy (as per standard practice for 3 months).', 'interventionNames': ['Drug: Nintedanib', 'Drug: Progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Progesterone Only', 'description': 'Progesterone therapy (as per standard practice for 3 months).', 'interventionNames': ['Drug: Progesterone']}], 'interventions': [{'name': 'Nintedanib', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Nintedanib + Progesterone']}, {'name': 'Progesterone', 'type': 'DRUG', 'description': 'For control group', 'armGroupLabels': ['Nintedanib + Progesterone', 'Progesterone Only']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "This involves the patient's informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Dean', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}