Fetal Penis LengthNCT01114867
Fetal Penile Length and Corpus Cavernosum Length - Normal Measurement Via Ultrasound
An observational study of Fetal Penis Length, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Hypothesis: Measurement of fetal penis length by ultrasound may be inaccurate when measured from the scrotum to the penile tip. we will provide normal values of penile length measured from the penile tip to the abdominal wall and measuring the corpus cavernosum length. Read more about this study
- Who is it for?
- Ages 14 to 34 weeks, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Penis Length
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to not given
- 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 34 weeks
- Men only
- Healthy volunteers accepted
- Child
Study population: Fetuses of healthy pregnant women
Who may be able to join
- pregnant women at 14th through 34th week gestation,
- routine ultrasound not preformed for anomalies at the genitourinary system,
- estimated fetal weight corresponds to gestational age.
Who cannot join
- women who's fetuses are suspected to be with fetal growth retardation,
- women who's fetuses are suspected to be with genitourinary anomaly.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ultrasound Unit in OBGYN, Soraski Medical Center
Tel Aviv, 64239
Yoseph Hartoov, Dr, +972-3-6925747
Arnon Agmon, Dr, +972-3-6925747, arnon@arnonagmon.com
About this study
Official title: Prospective Cross-sectional Study of Fetal Penis and Corpus Cavernosum Length
Hypothesis: Measurement of fetal penis length by ultrasound may be inaccurate when measured from the scrotum to the penile tip. we will provide normal values of penile length measured from the penile tip to the abdominal wall and measuring the corpus cavernosum length.
- Conditions
- Fetal Penis Length
- Keywords
- ultrasound, penis length, corpus cavernosum, length of fetal penis and fetal corpus cavernosum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Penis LengthStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Yoseph Hartoov, Dr, Principal investigator, Tel-Aviv, Soraski Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114867
- Sponsor's protocol ID
- TASMC-10-YH-0128-CTIL
- Status last verified
- Apr 2010
- First submitted
- 29 Apr 2010
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cross-sectional Study of Fetal Penis and Corpus Cavernosum Length
- ClinicalTrials.gov ID
- NCT01114867
- Acronym / sponsor ID
- TASMC-10-YH-0128-CTIL
- Conditions
- Fetal Penis Length
- Keywords
- ultrasound, penis length, corpus cavernosum, length of fetal penis and fetal corpus cavernosum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2010
- First posted
- 3 May 2010 (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.
Hypothesis: Measurement of fetal penis length by ultrasound may be inaccurate when measured from the scrotum to the penile tip. we will provide normal values of penile length measured from the penile tip to the abdominal wall and measuring the corpus cavernosum length.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 34 weeks
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Fetuses of healthy pregnant women
Key inclusion criteria (3 listed)
- pregnant women at 14th through 34th week gestation,
- routine ultrasound not preformed for anomalies at the genitourinary system,
- estimated fetal weight corresponds to gestational age.
Key exclusion criteria (2 listed)
- women who's fetuses are suspected to be with fetal growth retardation,
- women who's fetuses are suspected to be with genitourinary anomaly.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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.
Yoseph Hartoov, Dr principal investigator
Tel-Aviv, Soraski Medical Center
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 Fetal Penis Length, run by Tel-Aviv Sourasky 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 3 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: status not confirmed, as of the sponsor's last update on 27 Mar 2014. 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?
Results are not available in the source record.
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.
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 27 Mar 2014.