Examining hormonal profiles in infants with disorders of sex development
Evaluation of Minipuberty in Infants Born With a Variation in Sexual Development
This study is trying to understand the hormone levels in infants with disorders of sex development to see how they compare to other babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 9 Months |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT05058781 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on infants born with disorders of sex development (DSD) or those born to parents with congenital hypogonadism hypogonadotrope (CHH). The main objective is to evaluate the hormonal profiles during the minipuberty phase of these infants and compare them to control groups. By understanding the hormonal variations, the study aims to better characterize the underlying causes of DSD and CHH. The research will involve careful monitoring and assessment of hormonal levels in the specified infant population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants exhibiting symptoms of DSD or those born to parents with CHH.
Not a fit: Patients who are premature (less than 35 weeks of gestation) or male infants with high scrotal cryptorchidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of infants with DSD and CHH.
How similar studies have performed: While there is ongoing research in this area, the specific focus on hormonal profiles during minipuberty in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * infants born with symptoms of DSD * infants born from parents with CHH Exclusion Criteria: * premature \< 35 weeks of gestation * male infants with high scrotal cryptorchidism
Where this trial is running
Lausanne, Canton of Vaud
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nelly Pitteloud, MD — Chuv
- Study coordinator: Nelly Pitteloud, MD
- Email: nelly.pitteloud@chuv.ch
- Phone: +41 79 556 27 36
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.