Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2
1 other identifier
interventional
10
1 country
1
Brief Summary
Reduced hormone insulin-like 3, exclusively secreted by Leydig cells, has been identified as the recognized mechanism for cryptorchidism. Testicular macrophages residing in the testicular interstitium were thought to play a vital role in maintaining hormone secretion of Leydig cells. However, the contribution of macrophages to cryptorchidism remained poorly understood. Here, after 14 days of ketoconazole treatment, levels of both Trem2 and insulin-like 3 significantly decrease in human embryonic testes compared to the untreated control group. Conversely, 14 days of luteinizing hormone stimulation lead to elevated levels of Trem2 and insulin-like 3 in the testes compared to the untreated control group. Additionally, researchers find a positive correlation between Trem2 and insulin-like 3 expression in a human ex vivo tissue culture model. In summary, the study will propose Trem2 as a novel target for maintaining normal testicular descent by regulating the testicular immune microenvironment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2024
CompletedFirst Submitted
Initial submission to the registry
August 15, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 19, 2024
February 1, 2024
10 months
August 15, 2024
August 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative expression of Trem2 and insulin-like 3 protein
Ketoconazole promotes a decrease in Trem2 and a decrease in insulin-like 3, and they are strongly correlated.
The date of 14 days cultured
Study Arms (3)
Intact aborted fetal testicular tissue treated with ketoconazole
EXPERIMENTALA fetal developmental stage is precisely determined. Then, fetal tissues are extracted for in vitro cultivation. Intact aborted fetal testicular tissues are cultured in a medium containing 10-6 mol/L ketoconazole, which is the injectable solution powder. Ketoconazole is administered starting on the first day and then every other day, for a total of 7 times over the 14-day in vitro culture period.
Intact aborted fetal testicular tissue treated with luteinizing hormone
EXPERIMENTALA fetal developmental stage is precisely determined. Then, fetal tissues are extracted for in vitro cultivation. Intact aborted fetal testicular tissues are cultured in a medium containing 1 IU/mL luteinizing hormone, which is the injectable solution powder. Luteinizing hormone is administered starting on the first day and then every other day, for a total of 7 times over the 14-day in vitro culture period.
Intact aborted fetal testicular tissue treated with none
NO INTERVENTIONA fetal developmental stage is precisely determined. Then, fetal tissues are extracted for in vitro cultivation. Intact aborted fetal testicular tissues are cultured in a medium.
Interventions
A fetal developmental stage is precisely determined. Then, fetal tissues are extracted for in vitro cultivation. Intact aborted fetal testicular tissues are cultured in a medium containing 10-6 mol/L ketoconazole, which is the injectable solution powder. Ketoconazole is administered starting on the first day and then every other day, for a total of 7 times over the 14-day in vitro culture period.
A fetal developmental stage is precisely determined. Then, fetal tissues are extracted for in vitro cultivation. Intact aborted fetal testicular tissues are cultured in a medium containing 1 IU/mL luteinizing hormone, which is the injectable solution powder. Luteinizing hormone is administered starting on the first day and then every other day, for a total of 7 times over the 14-day in vitro culture period.
Eligibility Criteria
You may qualify if:
- \. Termination of pregnancy is not related to the health of the fetus.
- \. The fetus is intact in development and free of malformations and abnormalities.
- \. Estimation of gestational age based on parietal-rump length must be between 8 and 13 weeks of gestation.
You may not qualify if:
- \. The termination of pregnancy is related to the health of the fetus
- \. The fetus is not intact in development.
- \. The fetus has malformations, abnormalities
- \. Estimation of gestational age based on parietal-rump length must not be within 8-13 weeks of gestation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated hospital of nantong university
Nantong, Jiangsu, 226001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wenliang Ge
Affiliated Hospital of Nantong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2024
First Posted
August 19, 2024
Study Start
February 3, 2024
Primary Completion
December 1, 2024
Study Completion
December 31, 2024
Last Updated
August 19, 2024
Record last verified: 2024-02