Recurrent MiscarriageNCT06249230
The Analysis of Risk Factors for Recurrent Pregnancy Loss and Prediction of Pregnancy Loss Risk
An observational study of Recurrent Miscarriage, run by RenJi Hospital at 1 site in China.
Trial summary
Based on the comprehensive etiological screening results of patients with recurrent pregnancy loss, including basic characteristics, coagulation function indicators, autoimmune indicators, endocrine indicators, and gynecological ultrasound examination results, as well as the outcome of subsequent pregnancy after the… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Recurrent Miscarriage
- What is being tested?
- Hematologic features, Ultrasound indices of uterine artery blood flow and Demographic characteristics
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who had two or more spontaneous miscarriages (including biochemical pregnancies, excluding spontaneous miscarriages due to chromosomal abnormalities in the embryo) before 28 weeks of gestation with the same partner prior to the consultation were included in this study
Who may be able to join
- Diagnosis of recurrent miscarriage: patients who had two or more spontaneous miscarriages (including biochemical pregnancies, excluding spontaneous miscarriages due to chromosomal abnormalities in the embryo) before 28 weeks of gestation with the same partner prior to the consultation were included in this study;
- ≥20 years old;
- Completion of initial history taking and complete results of the etiological screening programme;
- Knowledge of the purpose and significance of the study, consent and sign the informed consent form;
Who cannot join
- Pregnant at the first visit;
- Presence of severe contraindications to pregnancy, making it inadvisable to conceive;
- Voluntary withdrawal from the pregnancy or from the study;
- No pregnancy outcome as of the follow-up endpoint (December 31, 2023), indicating no pregnancy;
- Loss to follow-up, unable to obtain pregnancy outcome;
- Subsequent pregnancy outcomes after the clinic visit included ectopic pregnancy, molar pregnancy, fetal malformations, and pregnancy at the scar site of previous cesarean section.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Mingyang Li, 86+15026849150, 1042217951@qq.com
About this study
Official title: A Retrospective Study on the Analysis of Risk Factors for Recurrent Pregnancy Loss and Prediction of Pregnancy Loss Risk in Patients With Recurrent Pregnancy Loss
Based on the comprehensive etiological screening results of patients with recurrent pregnancy loss, including basic characteristics, coagulation function indicators, autoimmune indicators, endocrine indicators, and gynecological ultrasound examination results, as well as the outcome of subsequent pregnancy after the patient's visit, analyze the independent risk factors affecting recurrent pregnancy loss, construct and validate an abortion risk prediction model to predict the risk of subsequent pregnancy loss in patients with recurrent pregnancy loss, and classify the patient's risk, Screening high-risk populations and guiding clinical early intervention and active treatment to improve pregnancy success rates.
Read the detailed description
- Study population and follow-up: Patients were routinely taken history information at the initial consultation and underwent at least two etiological screenings at intervals of 4-6 weeks; during this period, sex hormone tests and uterine artery ultrasonography were performed 5-9 days after ovulation. Autoantibody tests are considered abnormal if they are positive on two or more occasions. Combined with the results of the two etiological screenings and the results of sex hormone and uterine artery ultrasound, anticoagulant, antiplatelet or immunosuppressant medication will be given for at least 2 months, and then coagulation and immunological indexes and uterine artery ultrasound will be carried out again to assess whether the indexes are improved or not, and the patients who have reached the standard of preparation for pregnancy will be given the appropriate preparation for pregnancy based on the programme of assisted reproduction or natural conception. If the patient is not pregnant after three months of pregnancy preparation, outpatient consultation is required to reassess and adjust the regimen; if the patient is pregnant, outpatient consultation is required to assess the post-pregnancy situation and adjust the regimen; after that, platelet aggregation rate (AA and ADP), D-dimer and fibrin degradation product (FDP) will be monitored every fortnight, and every four weeks, autoantibodies, coagulation, liver and renal routines, blood counts, thyroid function, and the corresponding gestational week will be monitored. Obstetric ultrasonography was performed to adjust the medication in time. If the patient had a spontaneous abortion confirmed by ultrasonography or histology after curettage before 28 weeks of gestation, including biochemical pregnancy and embryonic arrest, the pregnancy outcome was judged as pregnancy loss, and if the patient was followed up with an intrauterine viable pregnancy beyond 32 weeks, the pregnancy outcome was judged as pregnancy success, and the reproductive immunity clinic follow-up was then ended. In this study, only the first pregnancy outcome after the initial visit was collected, and follow-up ended if the patient had a pregnancy outcome event. Patients who did not have a pregnancy outcome event as of 31 December 2023 were excluded from this study, and those who had a pregnancy outcome event were included in the study by compiling the history information collected at the initial visit of the included patients, and by querying the medical record system and entering the etiological screening laboratory indexes and ultrasound results as well as the outcome of the first pregnancy after the visit.
- Data collection: history collection at the initial consultation , outpatient medical record system query to collect laboratory indicators and ultrasound results, outpatient or telephone follow-up after the consultation of the outcome of the first pregnancy, "EpiData" software data entry;
- Data processing: data cleaning to remove duplicates, interpolation of missing values, categorisation of variables uniquely hot coding, elimination of heterozygous ratio <0.1 variables; characteristic Engineering descriptive statistics, correlation analysis, handling of outliers; data set division, the data were randomly divided into training set and test set according to the ratio of 7:3 according to the pregnancy outcome;
- Predictive factor screening: t-test, analysis of variance (ANOVA), non-parametric test, chi-square test, and other analyses of the risk factors of miscarriage in patients with recurrent miscarriages; or according to the results of the analysis in combination with the results of previous studies and clinical expertise or LASSO regression (the last absolute shrinkage and the last absolute shrinkage and the last absolute shrinkage and the last absolute shrinkage). (least absolute shrinkage and selection operator, LASSO regression). Method 1: A one-way analysis of variance (ANOVA) was performed in the training set to screen for risk factors associated with miscarriage in patients with recurrent miscarriage. Two independent samples t-tests were used for continuous data, and Mann-Whitney tests were used for non-normally distributed data; for categorical data, Chi-square tests or Fisher's exact test (FET) were used. For categorical data, Chi-square tests or Fisher's exact tests were used. A two-sided p-value of less than 0.05 was considered statistically significant. Differential variables were then included in a multifactorial logistic analysis with stepwise regression to screen for independent risk factors predicting pregnancy loss in patients with recurrent miscarriage. Method 2: LASSO regression (least absolute shrinkage and selection operator) was used for feature selection in the training set. The basic principle is to introduce the L1 regularisation term on the basis of ordinary least squares to achieve feature selection and coefficient sparsification of the model by minimising the objective function, screening the important features related to the outcome variable, while setting the coefficients of irrelevant or redundant features to zero. During the fitting process, the sparsity of features is controlled by adjusting the regularisation parameter. Optimal regularisation parameters are found using methods such as cross-validation or grid search. Obtain the coefficients of all features based on the trained Lasso regression model. Sort the coefficients, in descending order of absolute value. Set a threshold to retain features with coefficients greater than the threshold.
- Predictive model building: the training set data are taken to construct the model by machine learning methods such as logistic regression, K-nearest neighbour, decision tree, linear discriminant, neural network, random forest, support vector machine, gradient boosting, extreme gradient boosting, light gradient boosting or deep learning.
- Internal validation method: k-fold cross-validation is used within the training set to compare the model performance, select the optimal model to adjust the hyper-parameters, and then test the generalisation ability of the model in the test set.
- Comparison of model performance: calculate C-statistic (area under the curve AUC), accuracy, precision, recall, F1 score, and draw calibration curves, clinical decision curves and clinical impact curves to compare the prediction performance of different models.
- Risk stratification: patients are classified into low-risk and high-risk according to the model, which is applied to clinical assessment of patients and pregnancy supervision and management. Risk stratification is proposed to construct a column-line diagram based on logistic regression and calculate the column-line diagram score for each patient, and determine the optimal score threshold based on the Youden index; patients lower than or equal to the optimal score threshold are classified as low-risk subgroups, and patients higher than the optimal score threshold are classified as high-risk subgroups. The Pearson chi-square test was used to determine the validity of risk stratification by comparing the differences in pregnancy outcomes between the low-risk and high-risk subgroups.
- Model visualisation: column-line diagrams, risk score scales and "SHAP" were used to explain the model.
- Conditions
- Recurrent Miscarriage
- Being tested
- Hematologic features, Ultrasound indices of uterine artery blood flow, Demographic characteristics
- Keywords
- recurrent miscarriage, predictive modelling, risk stratification
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematologic featuresDiagnostic test
Hematologic features include coagulation indicators, autoimmune indicators, and endocrine indicators.
Ultrasound indices of uterine artery blood flowDiagnostic test
Ultrasound indices of uterine artery blood flow include endometrial thickness, endometrial artery blood flow parameters , and bilateral uterine artery blood flow parameters.
Demographic characteristicsOther
Demographic characteristics include age, the number of previous spontaneous abortions (including biochemical pregnancies), BMI, fertility history, past disease history, chromosomal status, family and genetic history, etc.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy success | Patients followed up with a live intrauterine pregnancy beyond 32 weeks were judged as pregnancy success. Receives: Diagnostic Test: Hematologic features; Diagnostic Test: Ultrasound indices of uterine artery blood flow; Other: Demographic characteristics | |
| Pregnancy loss | Patients with histologically confirmed spontaneous abortion by ultrasound or curettage before 28 weeks of gestation, including biochemical pregnancies and embryonic arrests, were judged as pregnancy loss Receives: Diagnostic Test: Hematologic features; Diagnostic Test: Ultrasound indices of uterine artery blood flow; Other: Demographic characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pregnancy success
If patients were followed up with a live intrauterine pregnancy beyond 32 weeks, the pregnancy outcome was determined to be a successful pregnancy and the reproductive immunology clinic follow-up ended .
Measured: Follow-up to 32 weeks of gestation for live intrauterine pregnancies or follow-up cut-off
Number of participants with pregnancy loss
Patients with histologically confirmed spontaneous abortion by ultrasound or curettage before 28 weeks of gestation, including biochemical pregnancies and embryonic arrests, were judged as pregnancy loss.
Measured: The time of spontaneous abortion occurring before 28 weeks of gestation after consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start31 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent MiscarriageStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimin Zhao, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249230
- Sponsor's protocol ID
- IIT-2023-0311
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Analysis of Risk Factors for Recurrent Pregnancy Loss and Prediction of Pregnancy Loss Risk in Patients With Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT06249230
- Acronym / sponsor ID
- IIT-2023-0311
- Conditions
- Recurrent Miscarriage
- Keywords
- recurrent miscarriage, predictive modelling, risk stratification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Feb 2024 (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.
Based on the comprehensive etiological screening results of patients with recurrent pregnancy loss, including basic characteristics, coagulation function indicators, autoimmune indicators, endocrine indicators, and gynecological ultrasound examination results, as well as the outcome of subsequent pregnancy after the patient's visit, analyze the independent risk factors affecting recurrent pregnancy loss, construct and validate an abortion risk prediction model to predict the risk of subsequent pregnancy loss in patients with recurrent pregnancy loss, and classify the patient's risk, Screening high-risk populations and guiding clinical early intervention and active treatment to improve pregnancy success rates.
Detailed description
- Study population and follow-up: Patients were routinely taken history information at the initial consultation and underwent at least two etiological screenings at intervals of 4-6 weeks; during this period, sex hormone tests and uterine artery ultrasonography were performed 5-9 days after ovulation. Autoantibody tests are considered abnormal if they are positive on two or more occasions. Combined with the results of the two etiological screenings and the results of sex hormone and uterine artery ultrasound, anticoagulant, antiplatelet or immunosuppressant medication will be given for at least 2 months, and then coagulation and immunological indexes and uterine artery ultrasound will be carried out again to assess whether the indexes are improved or not, and the patients who have reached the standard of preparation for pregnancy will be given the appropriate preparation for pregnancy based on the programme of assisted reproduction or natural conception. If the patient is not pregnant after three months of pregnancy preparation, outpatient consultation is required to reassess and adjust the regimen; if the patient is pregnant, outpatient consultation is required to assess the post-pregnancy situation and adjust the regimen; after that, platelet aggregation rate (AA and ADP), D-dimer and fibrin degradation product (FDP) will be monitored every fortnight, and every four weeks, autoantibodies, coagulation, liver and renal routines, blood counts, thyroid function, and the corresponding gestational week will be monitored. Obstetric ultrasonography was performed to adjust the medication in time. If the patient had a spontaneous abortion confirmed by ultrasonography or histology after curettage before 28 weeks of gestation, including biochemical pregnancy and embryonic arrest, the pregnancy outcome was judged as pregnancy loss, and if the patient was followed up with an intrauterine viable pregnancy beyond 32 weeks, the pregnancy outcome was judged as pregnancy success, and the reproductive immunity clinic follow-up was then ended. In this study, only the first pregnancy outcome after the initial visit was collected, and follow-up ended if the patient had a pregnancy outcome event. Patients who did not have a pregnancy outcome event as of 31 December 2023 were excluded from this study, and those who had a pregnancy outcome event were included in the study by compiling the history information collected at the initial visit of the included patients, and by querying the medical record system and entering the etiological screening laboratory indexes and ultrasound results as well as the outcome of the first pregnancy after the visit.
- Data collection: history collection at the initial consultation , outpatient medical record system query to collect laboratory indicators and ultrasound results, outpatient or telephone follow-up after the consultation of the outcome of the first pregnancy, "EpiData" software data entry;
- Data processing: data cleaning to remove duplicates, interpolation of missing values, categorisation of variables uniquely hot coding, elimination of heterozygous ratio <0.1 variables; characteristic Engineering descriptive statistics, correlation analysis, handling of outliers; data set division, the data were randomly divided into training set and test set according to the ratio of 7:3 according to the pregnancy outcome;
- Predictive factor screening: t-test, analysis of variance (ANOVA), non-parametric test, chi-square test, and other analyses of the risk factors of miscarriage in patients with recurrent miscarriages; or according to the results of the analysis in combination with the results of previous studies and clinical expertise or LASSO regression (the last absolute shrinkage and the last absolute shrinkage and the last absolute shrinkage and the last absolute shrinkage). (least absolute shrinkage and selection operator, LASSO regression). Method 1: A one-way analysis of variance (ANOVA) was performed in the training set to screen for risk factors associated with miscarriage in patients with recurrent miscarriage. Two independent samples t-tests were used for continuous data, and Mann-Whitney tests were used for non-normally distributed data; for categorical data, Chi-square tests or Fisher's exact test (FET) were used. For categorical data, Chi-square tests or Fisher's exact tests were used. A two-sided p-value of less than 0.05 was considered statistically significant. Differential variables were then included in a multifactorial logistic analysis with stepwise regression to screen for independent risk factors predicting pregnancy loss in patients with recurrent miscarriage. Method 2: LASSO regression (least absolute shrinkage and selection operator) was used for feature selection in the training set. The basic principle is to introduce the L1 regularisation term on the basis of ordinary least squares to achieve feature selection and coefficient sparsification of the model by minimising the objective function, screening the important features related to the outcome variable, while setting the coefficients of irrelevant or redundant features to zero. During the fitting process, the sparsity of features is controlled by adjusting the regularisation parameter. Optimal regularisation parameters are found using methods such as cross-validation or grid search. Obtain the coefficients of all features based on the trained Lasso regression model. Sort the coefficients, in descending order of absolute value. Set a threshold to retain features with coefficients greater than the threshold.
- Predictive model building: the training set data are taken to construct the model by machine learning methods such as logistic regression, K-nearest neighbour, decision tree, linear discriminant, neural network, random forest, support vector machine, gradient boosting, extreme gradient boosting, light gradient boosting or deep learning.
- Internal validation method: k-fold cross-validation is used within the training set to compare the model performance, select the optimal model to adjust the hyper-parameters, and then test the generalisation ability of the model in the test set.
- Comparison of model performance: calculate C-statistic (area under the curve AUC), accuracy, precision, recall, F1 score, and draw calibration curves, clinical decision curves and clinical impact curves to compare the prediction performance of different models.
- Risk stratification: patients are classified into low-risk and high-risk according to the model, which is applied to clinical assessment of patients and pregnancy supervision and management. Risk stratification is proposed to construct a column-line diagram based on logistic regression and calculate the column-line diagram score for each patient, and determine the optimal score threshold based on the Youden index; patients lower than or equal to the optimal score threshold are classified as low-risk subgroups, and patients higher than the optimal score threshold are classified as high-risk subgroups. The Pearson chi-square test was used to determine the validity of risk stratification by comparing the differences in pregnancy outcomes between the low-risk and high-risk subgroups.
- Model visualisation: column-line diagrams, risk score scales and "SHAP" were used to explain the model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnancy success | – | Diagnostic Test: Hematologic features, Diagnostic Test: Ultrasound indices of uterine artery blood flow, Other: Demographic characteristicsPatients followed up with a live intrauterine pregnancy beyond 32 weeks were judged as pregnancy success. |
| Pregnancy loss | – | Diagnostic Test: Hematologic features, Diagnostic Test: Ultrasound indices of uterine artery blood flow, Other: Demographic characteristicsPatients with histologically confirmed spontaneous abortion by ultrasound or curettage before 28 weeks of gestation, including biochemical pregnancies and embryonic arrests, were judged as pregnancy loss |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who had two or more spontaneous miscarriages (including biochemical pregnancies, excluding spontaneous miscarriages due to chromosomal abnormalities in the embryo) before 28 weeks of gestation with the same partner prior to the consultation were included in this study
Key inclusion criteria (4 listed)
- Diagnosis of recurrent miscarriage: patients who had two or more spontaneous miscarriages (including biochemical pregnancies, excluding spontaneous miscarriages due to chromosomal abnormalities in the embryo) before 28 weeks of gestation with the same partner prior to the consultation were included in this study;
- ≥20 years old;
- Completion of initial history taking and complete results of the etiological screening programme;
- Knowledge of the purpose and significance of the study, consent and sign the informed consent form;
Key exclusion criteria (6 listed)
- Pregnant at the first visit;
- Presence of severe contraindications to pregnancy, making it inadvisable to conceive;
- Voluntary withdrawal from the pregnancy or from the study;
- No pregnancy outcome as of the follow-up endpoint (December 31, 2023), indicating no pregnancy;
- Loss to follow-up, unable to obtain pregnancy outcome;
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 |
|---|---|---|
| Hematologic featuresHematologic features include coagulation indicators, autoimmune indicators, and endocrine indicators. | Diagnostic test | Pregnancy loss, Pregnancy success |
| Ultrasound indices of uterine artery blood flowUltrasound indices of uterine artery blood flow include endometrial thickness, endometrial artery blood flow parameters , and bilateral uterine artery blood flow parameters. | Diagnostic test | Pregnancy loss, Pregnancy success |
| Demographic characteristicsDemographic characteristics include age, the number of previous spontaneous abortions (including biochemical pregnancies), BMI, fertility history, past disease history, chromosomal status, family and genetic history, etc. | Other | Pregnancy loss, Pregnancy success |
Primary outcome
Number of participants with pregnancy success
Time frame: Follow-up to 32 weeks of gestation for live intrauterine pregnancies or follow-up cut-off
If patients were followed up with a live intrauterine pregnancy beyond 32 weeks, the pregnancy outcome was determined to be a successful pregnancy and the reproductive immunology clinic follow-up ended .
Number of participants with pregnancy loss
Time frame: The time of spontaneous abortion occurring before 28 weeks of gestation after consultation
Patients with histologically confirmed spontaneous abortion by ultrasound or curettage before 28 weeks of gestation, including biochemical pregnancies and embryonic arrests, were judged as pregnancy loss.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aimin Zhao, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Miscarriage, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingyang Li (86+15026849150, 1042217951@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pregnancy success (time frame: Follow-up to 32 weeks of gestation for live intrauterine pregnancies or follow-up cut-off). The study lists 2 primary outcomes in all. 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 12 Feb 2024.