PseudohermaphroditismNCT00173654
Mutation Analysis of 17βhydroxysteroid Dehydrogenase 3 Deficiency
An observational study of Pseudohermaphroditism, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Pseudohermaphroditism
- What is being tested?
- blood drawing
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2005to Aug 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with 17β-hydroxysteroid dehydrogenase 3 deficiency and their family
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yi-Ching Tung, MD, 886-2-23123456 ext. 5130, dtped004@yahoo.com.tw
About this study
To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.
Read the detailed description
17βhydroxysteroid dehydrogenase 3 (17βHSD3) deficiency is a rare cause of male pseudohermaphroditism. The incidence is reported to be 1: 147,000 in the Netherlands. Fewer than one hundred affected 46, XY males were reported in the literature, and no such case has been reported in Taiwan before. The 46, XY patients have ambiguious or complete female external genitalia. They are mostly unrecognized at birth and reared as female. They often draw medical attention when they receive operation for inguinal hernia or during puberty, clitoromegaly and musculization were noticed. However, the homozygous or compound heterozygous genetic females are asymptomatic. The 17βHSD3 catalyze the conversion of androstenedione to testosterone, the last step in the synthesis of testosterone. Therefore, the serum levels of androstenedione are elevated and testosterone or dihydrotestosterone are in the low range in these affected 46, XY individuals. The clinical diagnosis is made by HCG stimulation test, because androstenedione-to-testosterone ratio is abnormally elevated in these patients. But the molecular basis of 17βHSD3 deficiency was not determined till recent decade.
The HSD17B3 gene was elucidated in 1994, and composed of 11 exons. Several missence mutation and splice mutation were identified. But the precise action and tissue distribution of 17βHSD3 still need to be clarified. The Wölffian ducts virilze normally in the embryonic stage and the serum concentration of testosterone achieve to the normal range in the pubertal stage. The exact mechanism is not understood clearly and peripheral conversion under other isozymes was suggested in some studies.
The purpose of this study is to disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.
- Conditions
- Pseudohermaphroditism
- Being tested
- blood drawing
- Medical subject headings
- Disorders of Sex Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudohermaphroditismStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yi-Ching Tung, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173654
- Sponsor's protocol ID
- 9461700825
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 21 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutation Analysis of 17βhydroxysteroid Dehydrogenase 3 Deficiency
- ClinicalTrials.gov ID
- NCT00173654
- Acronym / sponsor ID
- 9461700825
- Conditions
- Pseudohermaphroditism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Aug 2006
- First posted
- 15 Sep 2005 (estimated)
- 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.
To disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.
Detailed description
17βhydroxysteroid dehydrogenase 3 (17βHSD3) deficiency is a rare cause of male pseudohermaphroditism. The incidence is reported to be 1: 147,000 in the Netherlands. Fewer than one hundred affected 46, XY males were reported in the literature, and no such case has been reported in Taiwan before. The 46, XY patients have ambiguious or complete female external genitalia. They are mostly unrecognized at birth and reared as female. They often draw medical attention when they receive operation for inguinal hernia or during puberty, clitoromegaly and musculization were noticed. However, the homozygous or compound heterozygous genetic females are asymptomatic. The 17βHSD3 catalyze the conversion of androstenedione to testosterone, the last step in the synthesis of testosterone. Therefore, the serum levels of androstenedione are elevated and testosterone or dihydrotestosterone are in the low range in these affected 46, XY individuals. The clinical diagnosis is made by HCG stimulation test, because androstenedione-to-testosterone ratio is abnormally elevated in these patients. But the molecular basis of 17βHSD3 deficiency was not determined till recent decade.
The HSD17B3 gene was elucidated in 1994, and composed of 11 exons. Several missence mutation and splice mutation were identified. But the precise action and tissue distribution of 17βHSD3 still need to be clarified. The Wölffian ducts virilze normally in the embryonic stage and the serum concentration of testosterone achieve to the normal range in the pubertal stage. The exact mechanism is not understood clearly and peripheral conversion under other isozymes was suggested in some studies.
The purpose of this study is to disclose the molecular pathology of our 3 families with 17βHSD3 deficiency.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with 17β-hydroxysteroid dehydrogenase 3 deficiency and their family
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2005.
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. This study is not recruiting at the moment.
Yi-Ching Tung, MD principal investigator
National Taiwan University Hospital
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 Pseudohermaphroditism, run by National Taiwan University Hospital at 1 site in Taiwan.
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 0 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: status not confirmed, as of the sponsor's last update on 21 Dec 2005. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Ching Tung, MD (886-2-23123456 ext. 5130, dtped004@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 21 Dec 2005.