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Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

A

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.
    1. The fetus is intact in development and free of malformations and abnormalities.
    1. 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
    1. The fetus is not intact in development.
    1. The fetus has malformations, abnormalities
    1. 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)

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.

Trial contacts and locations

1

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Central trial contact

Wenliang Ge

Data sourced from clinicaltrials.gov

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