Genetic Neurodevelopmental DisordersNCT07049042

Hypogonadotrophic Hypogonadism in Genetic Neurodevelopmental Conditions

An observational study of Genetic Neurodevelopmental Disorders, run by University of Sheffield at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 0 to 99 years
Conditions the study is for: Genetic Neurodevelopmental Disorders
How many people: 50 participants
Where: 1 siteUnited Kingdom
Study dates: 8 Jan 2025to 1 May 2029
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 0 to 99 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Individuals with pathogenic CNVs or SNVs in a gene causing a neurodevelopmental disorder. Especially SOX genes to investigate association with hypogonadism.

Who may be able to join

Pathogenic SNV or CNV in neurodevelopmental disorders gene of interest parent or carer consents to study

Who cannot join

parent or carer does not consent to study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting

Sheffield Childrens Hospital NHS Foundation Trust
Sheffield, Select, S11 9LE
Alisdair McNeill, FRPC PhD, 0114 222 2230, a.mcneill@sheffield.ac.uk
Recruiting

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About this study

Hypogonadism is the medical name for a condition in which levels of the hormones which control sexual development are lower than normal. There are dozens of different causes of hypogonadism. Many people with hypogonadism have a change in a gene. There are many genes that give instructions for the hormones important for sexual development. Changes in one of these genes that stops the gene from working, can cause hypogonadism. In some of these medical conditions, there are additional features such as learning problems. In this study we will search databases to find all the genetic conditions that can be associated with hypogonadism. We will ask a number of people with changes in certain genes, identified from our search, to come to our research clinic. We will ask them about their health and examine them for signs of hypogonadism. For some, we will take blood samples to test for hypogonadism. This project will help us understand how common hypogonadism is, in people with these genetic changes, which will help with their treatment.

Conditions: Genetic Neurodevelopmental Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of FSH
Blood sample to measure FSH levels.
FSH (IU/l) reference range Male, female 0 - 1 month <22.0 Roche 24.01.2011 Male 1 month - 6 years <2.8 Roche 24.01.2011 Male 6 - 11 years <3.8 Roche 24.01.2011 Male 11 - 14 years <4.6 Roche 24.01.2011 Male 14 years + 1.5 - 12 Roche 24.01.2011 Females 1 month - 14 years 0 - 11 Roche 24.01.2011 Follicular phase 3.5 - 13 Roche 24.01.2011 Mid-cycle 4.7 - 22 Roche 24.01.2011 Luteal phase 1.7 - 7.7 Roc
Measured: within 1 month of recruitment
Measurement of LH
Blood sample to assay LH levels. LH (IU/l) reference range Males 0 - 1 year <3.2 Wiedemann Males 1 - 11 years <1.4 Roche 24.01.2011 Males 11 - 14 years <7.8 Roche 24.01.2011 Males 14 - 17 years 1.3 - 9.8 Roche 24.01.2011 Males 17 years + 1.7 - 8.6 Roche 24.01.2011 Females 0 - 6 years <0.5 Roche 24.01.2011 Females 6 - 11 years <3.1 Roche 24.01.2011 Females 11 - 14 years <11.9 Roche 24.01.2011 Follicular Phase 2.4 - 13 Roche 24.01.2011 Mid - cycle 14 - 96 Roche 24.01.2011 Luteal phase 1.0 - 11 Roche 24.01.2011 Females 60y + (post-menopausal) 7.7 - 59 Roche 24.01.2011
Measured: within 1 month of recruitmen
Measurement of testosterone.
Blood assay of testosterone levels in males. Testosterone (nmol/l) Reference range Males, 6 months - 6 years <1.12 Roche 24.01.2011 Males 6 - 13 years <2.37 Roche 24.01.2011 Males 13 - 18 years 0.98 - 38.5 Roche 24.01.2011 Males 18 - 50 years 8.6 - 29 Roche 24.01.2011 Males 50 years + 6.7 - 25.7 Roche 24.01.2011 Females 0 - 1 month 0.7 - 2.2 Soldin 24.01.2011 Females 1 month - 10 years <0.4 Soldin 24.01.2011 Females 10 - 12 years <0.9 Soldin 24.01.2011 Females 12 years + 0.3 - 1.7 Roche 24.01.2011 Females 50 years + 0.1 - 1.4 Roche 24.01.2011
Measured: within 1 month of recruitment.
Physical examination for pubertal staging.
Tanner staging standard exam (testicular volume, body hair development, breast development).
Measured: within 1- month of recruitment.
General medical examination.
Height \& weight, dysmorphology exam. Full respiratory, cardiac and neurological exam.
Measured: within 1 month of recruitment
Bone age from x-ray.
X-ray assessment of bone age retrieved from medical notes (optional, only if done in routine clinical care previously).
Measured: within 1-month of recruitment.
Brain MRI
Result retrieved from medical records, optional only if done as part of routine care.
Measured: within 1 month of recruitment
Gonadal ultrasound
gonadal ultrasound, optional, if done by usual care team
Measured: within 1-month of recruitment
Serum oestradiol
Oestradiol (pmol/l) reference range Males 1 - 10 years 18.4 - 73.4 Roche 24.01.2011 Males aged 10 years + 41.4 - 159 Roche 07/09/2017 Females aged 1 - 10 years 22 - 99.1 Roche 24.01.2011 Follicular phase <91.8 - 854 Roche 02/08/2016 Ovulation phase 151 - 1461 Roche 02/08/2016 Luteal phase <91.8 - 1251 Roche 02/08/2016 Females post-menopausal <386 STH study 02/08/2016
Measured: within 1 month of recruitment
Serum AMH
AntiMullerian Hormone (pmol/l) 2.5th, 5th , Median, 95th
, 97.5th 20 - 24 yr 8.7, 10.9, 28.6, 71.0, 83.6 Roche 01/06/2018 25 - 29 yr 6.4, 8.6, 23.6, 64.6, 70.3 Roche 01/06/2018 30 - 34 yr 4.1, 5.1, 20.0, 54.2, 58.0 Roche 01/06/2018 35 - 39 yr 1.1, 2.9, 14.2, 49.7, 53.5 Roche 01/06/2018 40 - 44 yr 0.419, 0.4, 6.3, 31.7, 39.1 Roche 01/06/2018 45 - 50 yr 0.07, 0.07, 1.39, 12.8, 19.3 Roche 01/06/2018
Measured: within 1 month of recruitment
Serum thyroid function tests
Free T3 (pmol/l) reference ranges Males, females 0 - 6 days 2.7 - 9.7 Roche 24.01.2011 Males, females 6 days - 3 months 3.0 - 9.3 Roche 24.01.2011 Males, females 3 - 12 months 3.3 - 9.0 Roche 24.01.2011 Males, females 1 - 6 years 3.7 - 8.5 Roche 24.01.2011 Males, females 6 - 11 years 3.9 - 8.0 Roche 24.01.2011 Males, females 11 - 20 years 3.9 - 7.7 Roche 24.01.2011 Males, females 20 years + 3.1 - 6.8 Roche 24.01.2011 Pregnancy, first trimester 3.8 - 6.0 Roche 24.01.2011 Pregnancy, second trimester 3.2 - 5.5 Roche 24.01.2011 Pregnancy, third trimester 3.1 - 5.0 Roche 24.01.2011 Free T4 (pmol/l) Males, females 0 - 6 days 11.0 - 32.0 Roche 24.01.2011 Males, females 6 days - 3 months 11.5 - 28.3 Roche 24.01.2011 Males, females 3 - 12 months 11.9 - 25.6 Roche 24.01.2011 Males, females 1 year + 11.9 - 21.6 Roche 14.03.2023 Pregnancy, first trimester 12.1 - 19.6 Roche 24.01.2011 Pregnancy, second trimester 9.6 - 17 Roche 24.01.2011 Pregnancy, third trimester 8.4 - 15.6 Roche 24.01.2011
Measured: within 1 month of recruitment
Serum IGF1 level
GF-1 (µg/l) Males, 0 - 3 months No range (comment) 06.10.2020 Males, 3 - 6 months 12 - 94 Roche 06.10.2020 Males, 6 - 12 months 12 - 95 Roche 06.10.2020 Males, 1 year 12 - 96 Roche 06.10.2020 Males, 2 years 14 - 104 Roche 06.10.2020 Males, 3 years 19 - 116 Roche 06.10.2020 Males, 4 years 27 - 134 Roche 06.10.2020 Males, 5 years 37 - 156 Roche 06.10.2020 Males, 6 years 47 - 184 Roche 06.10.2020 Males, 7 years 58 - 216 Roche 06.10.2020 Males, 8 years 68 - 254 Roche 06.10.2020 Males, 9 years 77 - 296 Roche 06.10.2020 Males, 10 years 86 - 343 Roche 06.10.2020 Males, 11 years 94 - 392 Roche 06.10.2020 Males, 12 years 101 - 434 Roche 06.10.2020 Males, 13 years 108 - 467 Roche 06.10.2020 Males, 14 years 115 - 489 Roche 06.10.2020 Males, 15 years 120 - 501 Roche 06.10.2020 Males, 16 years 125 - 503 Roche 06.10.2020 Males, 17 years 129 - 495 Roche 06.10.2020 Males, 18 years 132 - 476 Roche 06.10.2020 Males, 19 years 134 - 450 Roche 06.10.2020 Males, 20 years 136 - 421 Roche 06.10.2020 Males, 2
Measured: within 1 month recruitment
Serum prolactin
Males, females 0 - 1 year No range (comment) Males 1 year + 86 - 324 Roche 24.01.2011 Females 1 year + 102 - 496 Roche 24.01.2011
Measured: within 1-month recruitment
serum cortisol
Cortisol (nmol/l) Neonates 50 - 300 Sippell et al 01.06.2012 Adults 6 - 10 am 4 - 8 pm
Random or 8.30-9.30 am:
Adrenal insufficiency unlikely (NB does not apply to sick patients with high index of suspicion)
Synacthen test (30 min cort):
Primary adrenal insufficiency unlikely 133 - 537 68 - 327
>/=350 >430 Wythenshawe In-house In-house 18.04.2016 21/12/2018 21/12/2018
Measured: within 1 month recruitment
serum ACTH
ACTH, 7 am - 10 am (ng/l) 7.2 - 63.3 Roche 22/10/2018
Measured: within 1-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 20251 May 2029

First posted3 Jul 2025
Study start8 Jan 2025
Primary completion1 May 2029 (estimated)
Study completion1 May 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Genetic Neurodevelopmental DisordersStudies of the same condition, open and under way.
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: Cohort
Time perspective: Prospective
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07049042
Sponsor's protocol ID: 340777
Status last verified: Jun 2025
First submitted: 15 Feb 2024
Last updated: 3 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Genetic Neurodevelopmental Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hypogonadotrophic Hypogonadism in Genetic Neurodevelopmental Conditions
ClinicalTrials.gov ID: NCT07049042
Acronym / sponsor ID: 340777
Conditions: Genetic Neurodevelopmental Disorders
Study type: Observational
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: University of SheffieldUniversity, hospital or other
Study start: 8 Jan 2025 (actual)
Primary completion: 1 May 2029 (estimated)
Study completion: 1 May 2029 (estimated)
First posted: 3 Jul 2025 (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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 0 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Individuals with pathogenic CNVs or SNVs in a gene causing a neurodevelopmental disorder. Especially SOX genes to investigate association with hypogonadism.

Key inclusion criteria (1 listed)

Pathogenic SNV or CNV in neurodevelopmental disorders gene of interest parent or carer consents to study

Key exclusion criteria (1 listed)

parent or carer does not consent to study

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

Measurement of FSH
Time frame: within 1 month of recruitment
Blood sample to measure FSH levels. FSH (IU/l) reference range Male, female 0 - 1 month <22.0 Roche 24.01.2011 Male 1 month - 6 years <2.8 Roche 24.01.2011 Male 6 - 11 years <3.8 Roche 24.01.2011 Male 11 - 14 years <4.6 Roche 24.01.2011 Male 14 years + 1.5 - 12 Roche 24.01.2011 Females 1 month - 14 years 0 - 11 Roche 24.01.2011 Follicular phase 3.5 - 13 Roche 24.01.2011 Mid-cycle 4.7 - 22 Roche 24.01.2011 Luteal phase 1.7 - 7.7 Roc
Measurement of LH
Time frame: within 1 month of recruitmen
Blood sample to assay LH levels. LH (IU/l) reference range Males 0 - 1 year <3.2 Wiedemann Males 1 - 11 years <1.4 Roche 24.01.2011 Males 11 - 14 years <7.8 Roche 24.01.2011 Males 14 - 17 years 1.3 - 9.8 Roche 24.01.2011 Males 17 years + 1.7 - 8.6 Roche 24.01.2011 Females 0 - 6 years <0.5 Roche 24.01.2011 Females 6 - 11 years <3.1 Roche 24.01.2011 Females 11 - 14 years <11.9 Roche 24.01.2011 Follicular Phase 2.4 - 13 Roche 24.01.2011 Mid - cycle 14 - 96 Roche 24.01.2011 Luteal phase 1.0 - 11 Roche 24.01.2011 Females 60y + (post-menopausal) 7.7 - 59 Roche 24.01.2011
Measurement of testosterone.
Time frame: within 1 month of recruitment.
Blood assay of testosterone levels in males. Testosterone (nmol/l) Reference range Males, 6 months - 6 years <1.12 Roche 24.01.2011 Males 6 - 13 years <2.37 Roche 24.01.2011 Males 13 - 18 years 0.98 - 38.5 Roche 24.01.2011 Males 18 - 50 years 8.6 - 29 Roche 24.01.2011 Males 50 years + 6.7 - 25.7 Roche 24.01.2011 Females 0 - 1 month 0.7 - 2.2 Soldin 24.01.2011 Females 1 month - 10 years <0.4 Soldin 24.01.2011 Females 10 - 12 years <0.9 Soldin 24.01.2011 Females 12 years + 0.3 - 1.7 Roche 24.01.2011 Females 50 years + 0.1 - 1.4 Roche 24.01.2011
Physical examination for pubertal staging.
Time frame: within 1- month of recruitment.
Tanner staging standard exam (testicular volume, body hair development, breast development).
General medical examination.
Time frame: within 1 month of recruitment
Height \& weight, dysmorphology exam. Full respiratory, cardiac and neurological exam.
Bone age from x-ray.
Time frame: within 1-month of recruitment.
X-ray assessment of bone age retrieved from medical notes (optional, only if done in routine clinical care previously).
Brain MRI
Time frame: within 1 month of recruitment
Result retrieved from medical records, optional only if done as part of routine care.
Gonadal ultrasound
Time frame: within 1-month of recruitment
gonadal ultrasound, optional, if done by usual care team
Serum oestradiol
Time frame: within 1 month of recruitment
Oestradiol (pmol/l) reference range Males 1 - 10 years 18.4 - 73.4 Roche 24.01.2011 Males aged 10 years + 41.4 - 159 Roche 07/09/2017 Females aged 1 - 10 years 22 - 99.1 Roche 24.01.2011 Follicular phase <91.8 - 854 Roche 02/08/2016 Ovulation phase 151 - 1461 Roche 02/08/2016 Luteal phase <91.8 - 1251 Roche 02/08/2016 Females post-menopausal <386 STH study 02/08/2016
Serum AMH
Time frame: within 1 month of recruitment
AntiMullerian Hormone (pmol/l) 2.5th, 5th , Median, 95th , 97.5th 20 - 24 yr 8.7, 10.9, 28.6, 71.0, 83.6 Roche 01/06/2018 25 - 29 yr 6.4, 8.6, 23.6, 64.6, 70.3 Roche 01/06/2018 30 - 34 yr 4.1, 5.1, 20.0, 54.2, 58.0 Roche 01/06/2018 35 - 39 yr 1.1, 2.9, 14.2, 49.7, 53.5 Roche 01/06/2018 40 - 44 yr 0.419, 0.4, 6.3, 31.7, 39.1 Roche 01/06/2018 45 - 50 yr 0.07, 0.07, 1.39, 12.8, 19.3 Roche 01/06/2018
Serum thyroid function tests
Time frame: within 1 month of recruitment
Free T3 (pmol/l) reference ranges Males, females 0 - 6 days 2.7 - 9.7 Roche 24.01.2011 Males, females 6 days - 3 months 3.0 - 9.3 Roche 24.01.2011 Males, females 3 - 12 months 3.3 - 9.0 Roche 24.01.2011 Males, females 1 - 6 years 3.7 - 8.5 Roche 24.01.2011 Males, females 6 - 11 years 3.9 - 8.0 Roche 24.01.2011 Males, females 11 - 20 years 3.9 - 7.7 Roche 24.01.2011 Males, females 20 years + 3.1 - 6.8 Roche 24.01.2011 Pregnancy, first trimester 3.8 - 6.0 Roche 24.01.2011 Pregnancy, second trimester 3.2 - 5.5 Roche 24.01.2011 Pregnancy, third trimester 3.1 - 5.0 Roche 24.01.2011 Free T4 (pmol/l) Males, females 0 - 6 days 11.0 - 32.0 Roche 24.01.2011 Males, females 6 days - 3 months 11.5 - 28.3 Roche 24.01.2011 Males, females 3 - 12 months 11.9 - 25.6 Roche 24.01.2011 Males, females 1 year + 11.9 - 21.6 Roche 14.03.2023 Pregnancy, first trimester 12.1 - 19.6 Roche 24.01.2011 Pregnancy, second trimester 9.6 - 17 Roche 24.01.2011 Pregnancy, third trimester 8.4 - 15.6 Roche 24.01.2011
Serum IGF1 level
Time frame: within 1 month recruitment
GF-1 (µg/l) Males, 0 - 3 months No range (comment) 06.10.2020 Males, 3 - 6 months 12 - 94 Roche 06.10.2020 Males, 6 - 12 months 12 - 95 Roche 06.10.2020 Males, 1 year 12 - 96 Roche 06.10.2020 Males, 2 years 14 - 104 Roche 06.10.2020 Males, 3 years 19 - 116 Roche 06.10.2020 Males, 4 years 27 - 134 Roche 06.10.2020 Males, 5 years 37 - 156 Roche 06.10.2020 Males, 6 years 47 - 184 Roche 06.10.2020 Males, 7 years 58 - 216 Roche 06.10.2020 Males, 8 years 68 - 254 Roche 06.10.2020 Males, 9 years 77 - 296 Roche 06.10.2020 Males, 10 years 86 - 343 Roche 06.10.2020 Males, 11 years 94 - 392 Roche 06.10.2020 Males, 12 years 101 - 434 Roche 06.10.2020 Males, 13 years 108 - 467 Roche 06.10.2020 Males, 14 years 115 - 489 Roche 06.10.2020 Males, 15 years 120 - 501 Roche 06.10.2020 Males, 16 years 125 - 503 Roche 06.10.2020 Males, 17 years 129 - 495 Roche 06.10.2020 Males, 18 years 132 - 476 Roche 06.10.2020 Males, 19 years 134 - 450 Roche 06.10.2020 Males, 20 years 136 - 421 Roche 06.10.2020 Males, 2
Serum prolactin
Time frame: within 1-month recruitment
Males, females 0 - 1 year No range (comment) Males 1 year + 86 - 324 Roche 24.01.2011 Females 1 year + 102 - 496 Roche 24.01.2011
serum cortisol
Time frame: within 1 month recruitment
Cortisol (nmol/l) Neonates 50 - 300 Sippell et al 01.06.2012 Adults 6 - 10 am 4 - 8 pm Random or 8.30-9.30 am: Adrenal insufficiency unlikely (NB does not apply to sick patients with high index of suspicion) Synacthen test (30 min cort): Primary adrenal insufficiency unlikely 133 - 537 68 - 327 >/=350 >430 Wythenshawe In-house In-house 18.04.2016 21/12/2018 21/12/2018
serum ACTH
Time frame: within 1-month
ACTH, 7 am - 10 am (ng/l) 7.2 - 63.3 Roche 22/10/2018

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 3 Jul 2025.
Individual participant dataSharing planned: No

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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.

Sheffield Childrens Hospital NHS Foundation Trust

Sheffield, United Kingdom

0114 222 2230

a.mcneill@sheffield.ac.uk

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 Genetic Neurodevelopmental Disorders, run by University of Sheffield at 1 site in United Kingdom.

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 1 inclusion and 1 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 3 Jul 2025. 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 United Kingdom. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of FSH (time frame: within 1 month of recruitment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07049042.

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 3 Jul 2025.