DSDMiniNONCT05058781
Minipuberty in Infants Born With Potential Hypogonadism Hypogonadotrope
An observational study of DSD and CHH, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 9 monthsHealthy volunteers can take part
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2017to 31 Dec 2030
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: All infants born in canton de Vaud in Switzerland
Who may be able to join
- infants born with symptoms of DSD
- infants born from parents with CHH
Who cannot join
- premature < 35 weeks of gestation
- male infants with high scrotal cryptorchidism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Emmanuelle Paccou, +41 79 556 60 13, emmanuelle.paccou@chuv.ch
Argnesa Stojkaj, +41 79 556 37 50, argnesa.stojkaj@chuv.ch
About this study
Official title: Evaluation of Minipuberty in Infants Born With a Variation in Sexual Development
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hormonal changes in blood and in urine during minipuberty (LH, FSH, steroid profile, Testosterone, Estradiol (in girls), AMH, inhibin B)
Reproductive profile:
LH and FSH (UI/L) steroid profile (nmol/L) Testosterone and Estradiol (nmol/L) AMH (ng/mL) inhibin B (pg/mL)
Measured: at 2, 6 and 9 months of age (window for minipuberty)
Secondary outcomes (2)
quantification of Nitric Oxide metabolites during minipuberty
measurements of Nitrite (NO2-) and nitrate (NO3-) in blood
Measured: at 2, 6 and 9 months of age
change in expression of genes involved in the NO pathway
RNA sequencing of samples collected in blood
Measured: at birth (if available), 2, 6 and 9 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DSDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelly Pitteloud, Centre Hospitalier Universitaire Vaudois
- Investigators
- Nelly Pitteloud, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058781
- Sponsor's protocol ID
- CER-VD 2016-01232
- Acronym
- MiniNO
- Status last verified
- Jul 2022
- First submitted
- 17 Sep 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Minipuberty in Infants Born With a Variation in Sexual Development
- ClinicalTrials.gov ID
- NCT05058781
- Acronym / sponsor ID
- MiniNO / CER-VD 2016-01232
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Years
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All infants born in canton de Vaud in Switzerland
Key inclusion criteria (2 listed)
- infants born with symptoms of DSD
- infants born from parents with CHH
Key exclusion criteria (2 listed)
- premature < 35 weeks of gestation
- male infants with high scrotal cryptorchidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
quantification of Nitric Oxide metabolites during minipuberty
Time frame: at 2, 6 and 9 months of age
change in expression of genes involved in the NO pathway
Time frame: at birth (if available), 2, 6 and 9 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nelly Pitteloud, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DSD and CHH, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nelly Pitteloud, MD (+41 79 556 27 36, nelly.pitteloud@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.