Ketoconazole's effect on testicular development in cryptorchidism
Ketoconazole Contributes to Cryptorchidism Outcome Via Modulating Testicular Macrophage Trem2
This study is testing if ketoconazole can help improve testicular development in boys with undescended testicles by looking at how it affects certain immune cells and hormone levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 8 Weeks to 13 Weeks |
| Sex | Male |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06560086 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of ketoconazole in improving outcomes for cryptorchidism by modulating macrophage activity, specifically targeting Trem2 expression. It examines the relationship between testicular macrophages and Leydig cell hormone secretion, focusing on insulin-like 3 levels. The study involves treating human embryonic testes with ketoconazole for 14 days and comparing the results to untreated controls, alongside luteinizing hormone stimulation to assess its effects on Trem2 and hormone levels. The goal is to establish Trem2 as a potential therapeutic target for promoting normal testicular descent.
Who should consider this trial
Good fit: Ideal candidates for this study are fetuses between 8 and 13 weeks of gestation with intact development and no malformations.
Not a fit: Patients whose pregnancies are terminated due to fetal health issues or those with developmental abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment strategies for cryptorchidism, potentially enhancing testicular development and function.
How similar studies have performed: While the specific approach of targeting Trem2 in this context may be novel, previous studies have explored the role of macrophages in testicular function, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nantong, Jiangsu
- Affiliated hospital of nantong university — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Wenliang Ge
- Email: gewl@ntu.edu.cn
- Phone: 13962854122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.