Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Cryptorchidism

Treatments: Drug: Luteinizing Hormone; Drug: Ketoconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT06560086

82171587

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 8 to 13 weeks old

Volunteers: 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Intact aborted fetal testicular tissue treated with ketoconazole

Experimental group

Description:

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.

Treatment:

Drug: Ketoconazole

Intact aborted fetal testicular tissue treated with luteinizing hormone

Experimental group

Description:

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.

Treatment:

Drug: Luteinizing Hormone

Intact aborted fetal testicular tissue treated with none

No Intervention group

Description:

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.