An interventional study of Ketoconazole and Luteinizing Hormone in Cryptorchidism, sponsored by Affiliated Hospital of Nantong University. Recruiting at 1 site in China. Open to male participants aged 8 Weeks to 13 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Affiliated Hospital of Nantong University · Not applicable, Interventional, and Basic science
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.
40 studies on the registry are indexed under Cryptorchidism; 14 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 26 interventional studies indexed under Cryptorchidism.
Browse Cryptorchidism studies →Affiliated Hospital of Nantong University is the lead sponsor of 97 studies on the registry; 57 are open to participants now.
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Exclusion Criteria:
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.
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 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.
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.
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.
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.
Time frame: The date of 14 days cultured
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Studies of the drugs tested here: Ketoconazole · Luteinizing Hormone
Affiliated Hospital of Nantong University