Minipuberty in Infants Born With Potential Hypogonadism Hypogonadotrope

NCT ID: NCT05058781

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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DSD CHH

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Nelly Pitteloud

Professor, Head od Endocrine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nelly Pitteloud, MD

Role: PRINCIPAL_INVESTIGATOR

CHUV

Locations

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Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Nelly Pitteloud, MD

Role: CONTACT

+41 79 556 27 36

Research assistant

Role: CONTACT

+41 (0)79 556 37 50

Facility Contacts

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Emmanuelle Paccou

Role: primary

+41 79 556 60 13

Argnesa Stojkaj

Role: backup

+41 79 556 37 50

Other Identifiers

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CER-VD 2016-01232

Identifier Type: -

Identifier Source: org_study_id

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