Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

NCT06560086 — Not applicable, Unknown, 10 participants, Affiliated Hospital of Nantong University

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Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Testicular Macrophage Trem2

Registry	NCT06560086
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, basic science
Enrollment	10 (Estimated)
Sponsor	Affiliated Hospital of Nantong University (Other)
Conditions	Cryptorchidism
Interventions	Ketoconazole, Luteinizing Hormone (Drug)
Dates	start 2024-02-03, primary completion 2024-12-01 (estimated), completion 2024-12-31 (estimated), first posted 2024-08-19, last updated 2024-08-19
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intact aborted fetal testicular tissue treated with ketoconazole	Experimental	Drug: Ketoconazole	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.
Intact aborted fetal testicular tissue treated with luteinizing hormone	Experimental	Drug: Luteinizing 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.
Intact aborted fetal testicular tissue treated with none	No intervention		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.

Ketoconazole (Drug): 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.
Luteinizing Hormone (Drug): 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.

+Outcome measures

Primary outcomes

Relative expression of Trem2 and insulin-like 3 protein [The date of 14 days cultured]: Ketoconazole promotes a decrease in Trem2 and a decrease in insulin-like 3, and they are strongly correlated.

+Eligibility

Sex: Male, ages: 8 Weeks to 13 Weeks, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Affiliated hospital of nantong university	Nantong, Jiangsu	China	Recruiting

+Investigators

Wenliang Ge, Study director, Affiliated Hospital of Nantong University