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Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Testicular Macrophage Trem2

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06560086
Enrollment
10
Registered
2024-08-19
Start date
2024-02-03
Completion date
2024-12-31
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptorchidism

Keywords

cryptorchidism, testicular macrophages, Leydig cells, immune micro-environment

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.

Interventions

DRUGKetoconazole

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.

DRUGLuteinizing Hormone

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.

Sponsors

Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
8 Weeks to 13 Weeks
Healthy volunteers
Yes

Inclusion criteria

* 1\. Termination of pregnancy is not related to the health of the fetus. * 2\. The fetus is intact in development and free of malformations and abnormalities. * 3\. Estimation of gestational age based on parietal-rump length must be between 8 and 13 weeks of gestation.

Exclusion criteria

* 1\. The termination of pregnancy is related to the health of the fetus * 2\. The fetus is not intact in development. * 3\. The fetus has malformations, abnormalities * 4\. Estimation of gestational age based on parietal-rump length must not be within 8-13 weeks of gestation.

Design outcomes

Primary

MeasureTime frameDescription
Relative expression of Trem2 and insulin-like 3 proteinThe date of 14 days culturedKetoconazole promotes a decrease in Trem2 and a decrease in insulin-like 3, and they are strongly correlated.

Countries

China

Contacts

Primary ContactWenliang Ge
gewl@ntu.edu.cn13962854122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026