Ambiguous GenitaliaNCT01011400
Ultrasonic Measurements of the Clitoris in Fetuses
An observational study of Ambiguous Genitalia, run by Meir Medical Center at 1 site in Israel.
Trial summary
Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. To the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. Read more about this study
- Who is it for?
- Ages 14 to 37 weeks, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ambiguous Genitalia
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Dec 2011
- 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 14 to 37 weeks
- Women only
- Healthy volunteers accepted
- Child
Study population: pregnant women with a female fetus in the second or 3 ed trimester
Who may be able to join
- well dated pregnancy
- singleton pregnancy
- female fetus
- appropriate for gestational age
Who cannot join
- small for gestational age
- other fetal anomalies
- maternal conditions that can cause exposure of the fetus to high androgen environment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurements of the Fetal Clitoris by 2D Ultrasound
Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. To the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. The purpose of this study is to create a nomogram of clitorial size through gestation by measuring its size in fetuses of different age in the second and third trimester.
- Conditions
- Ambiguous Genitalia
- Keywords
- clitoris
- Medical subject headings
- Disorders of Sex Development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambiguous GenitaliaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011400
- Sponsor's protocol ID
- 121-09
- Status last verified
- Aug 2013
- First submitted
- 10 Nov 2009
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of the Fetal Clitoris by 2D Ultrasound
- ClinicalTrials.gov ID
- NCT01011400
- Acronym / sponsor ID
- 121-09
- Conditions
- Ambiguous Genitalia
- Keywords
- clitoris
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Nov 2009 (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.
Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. To the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. The purpose of this study is to create a nomogram of clitorial size through gestation by measuring its size in fetuses of different age in the second and third trimester.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 37 weeks
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pregnant women with a female fetus in the second or 3 ed trimester
Key inclusion criteria (4 listed)
- well dated pregnancy
- singleton pregnancy
- female fetus
- appropriate for gestational age
Key exclusion criteria (3 listed)
- small for gestational age
- other fetal anomalies
- maternal conditions that can cause exposure of the fetus to high androgen environment
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ambiguous Genitalia, run by Meir Medical Center at 1 site in Israel.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 Aug 2013. 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 Israel. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 28 Aug 2013.