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NCT Number: NCT05058781

Minipuberty in Infants Born With Potential Hypogonadism Hypogonadotrope

Disorders of sex development (DSD) occur in 1/3000 births and are defined by variation in aspect of external genital organs, e.g. cryptorchidism, hypospadias and micropenis in male infants and clitoral hypertrophy in female infants. Genetic, hormonal and environmental factors are implicated in DSD. Infants with congenital hypogonadism hypogonadotrope (CHH) can present with DSD. Evaluation of hormonal profile during minipuberty could be of great help to better characterize the etiology of DSD and CHH in particular. Our main objective is to study hormonal profile during the minipuberty of infants born with DSD or born from parents with CHH compared to controls.

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Key information

Conditions

DSD CHH

Age range

Up to 9 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hormonal changes in blood and in urine during minipuberty (LH, FSH, steroid profile, Testosterone, Estradiol (in girls), AMH, inhibin B)

    Time frame: at 2, 6 and 9 months of age (window for minipuberty)

    Reproductive profile:

    LH and FSH (UI/L) steroid profile (nmol/L) Testosterone and Estradiol (nmol/L) AMH (ng/mL) inhibin B (pg/mL)

Secondary outcomes

  1. quantification of Nitric Oxide metabolites during minipuberty

    Time frame: at 2, 6 and 9 months of age

    measurements of Nitrite (NO2-) and nitrate (NO3-) in blood

  2. change in expression of genes involved in the NO pathway

    Time frame: at birth (if available), 2, 6 and 9 months of age

    RNA sequencing of samples collected in blood

Study contacts

Contact information is provided by the study sponsor or research team.

Nelly Pitteloud, MD

CONTACT

[email protected]

+41 79 556 27 36

Research assistant

CONTACT

[email protected]

+41 (0)79 556 37 50

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Evaluation of Minipuberty in Infants Born With a Variation in Sexual Development

Acronym: MiniNO

Important dates

Study start
2017
Primary completion
2026
Study completion
2030
First posted
Sep 28, 2021
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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