Actively Recruiting
Evaluation of Minipuberty in Infants Born With a Variation in Sexual Development
Led by Centre Hospitalier Universitaire Vaudois · Updated on 2022-07-22
100
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Disorders of sex development (DSD) affect about 1 in 3,000 births and involve variations in the external genital organs, such as cryptorchidism, hypospadias, micropenis in male infants, and clitoral enlargement in female infants. Genetic, hormonal, and environmental factors can contribute to DSD. Infants with congenital hypogonadotropic hypogonadism (CHH) may show signs of DSD, and studying hormonal profiles during minipuberty could help clarify the causes of DSD and CHH. This observational study examines the hormonal changes in infants born with DSD or born to parents with CHH, comparing them to healthy controls. Researchers will measure hormones like LH, FSH, testosterone, estradiol (in girls), AMH, and inhibin B, as well as nitric oxide metabolites and gene expression related to nitric oxide pathways. These measurements occur at 2, 6, and 9 months of age, capturing the minipuberty period. Participants will be infants up to 9 months old who meet specific criteria. The study involves collecting blood and urine samples at the specified ages to track hormonal and molecular changes. Researchers aim to better understand hormonal profiles during minipuberty in affected infants. The study is sponsored by Centre Hospitalier Universitaire Vaudois and is planned to continue until the end of 2030.
CONDITIONS
Brief Title
Minipuberty in Infants Born With Potential Hypogonadism Hypogonadotrope
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born with symptoms of disorders of sex development (DSD)
- Infants born from parents with congenital hypogonadotropic hypogonadism (CHH)
You will not qualify if you...
- Premature infants born before 35 weeks of gestation
- Male infants with high scrotal cryptorchidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From birth to 9 months of age
Participants are observed and hormonal and genetic measurements are collected during the minipuberty period.
3 visits at approximately 2, 6, and 9 months of age
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
Research Team
N
Nelly Pitteloud, MD
R
Research assistant
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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