Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Macrophage Trem2

NCT ID: NCT06560086

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-03
• Study Completion Date: 2024-12-31

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.

Conditions

Cryptorchidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intact aborted fetal testicular tissue treated with 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.

Group Type: EXPERIMENTAL

Ketoconazole

Intervention Type: 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.

Intact aborted fetal testicular tissue treated with 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.

Group Type: EXPERIMENTAL

Luteinizing Hormone

Intervention Type: 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.

Intact aborted fetal testicular tissue treated with none

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Weeks
• Maximum Eligible Age: 13 Weeks
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenliang Ge

Role: STUDY_DIRECTOR

Affiliated Hospital of Nantong University

Locations

Affiliated hospital of nantong university

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenliang Ge

Role: CONTACT

gewl@ntu.edu.cn

13962854122

Facility Contacts

Wenliang Ge, Dr

Role: primary

gewl@ntu.edu.cn

13962854122

Other Identifiers

82171587

Identifier Type: -

Identifier Source: org_study_id