Nintedanib for Improving Reproductive Outcomes in Adenomyosis
ConditionAdenomyosis of Uterus
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age20-38
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Nintedanib
DrugParticipants 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.
Progesterone
DrugFor control group
Treatment groups
328 Participants
are divided into 2 treatment groupsGroup A: Nintedanib + ProgesteroneExperimental treatment 2 interventions
Group B: Progesterone OnlyActive comparator 1 intervention
Trial outcomes
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%.
Time frame
Up to approximately 9-12 months after embryo transfer (considering gestation)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: