MicropenisNCT01659528
Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy
An observational study of Micropenis, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to establish nomograms of penile length and width throughout the weeks of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Micropenis
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2012to Jul 2014
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women addressing for routine ultrasound scan at the ultrasound unit.
Who may be able to join
- Singleton pregnancy
- Proper pregnancy dating
- Normal fetal anatomical scan
- Gestational age 14 to 37 weeks
- Women aged 18 to 50
Who cannot join
- Multiple pregnancy
- Gestational age under 14 or above 37 weeks
- Fetus Small or Large for gestational age
- Abnormal anatomical scan or women who didn't perform such scan
- Minors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy - A Prospective Descriptive Study.
The purpose of this study is to establish nomograms of penile length and width throughout the weeks of pregnancy.
Read the detailed description
Identifying pathology of male genitalia is important. It can be an isolated pathology, or connected to disorders in other organs, as part of genetic syndromes or endocrine disorders. Micropenis is a disorder, which is important to diagnose in the womb. Micropenis is defined as a penis which is measured 2.5 standard deviation below average. It is also thinner by diameter. This finding can also be the first expression of a lethal hormonal deficiency, hence the reason for early detection by ultrasound during pregnancy.
Past prenatal diagnosis ultrasound studies, measured the penis from the scrotum to the tip of the penis. Another study evaluated formalin fixated fetuses after pregnancy terminations, in which the penis was measured from the abdominal wall to the tip of the penis. To date there are no nomograms for penile length, via ultrasound measurement from abdominal wall or for penile width. The investigators assume that measuring the penis from the abdominal wall is more accurate and standard than from the end of the scrotum, which is a less definitive reference point.
The investigators aim to establish nomograms of penile length throughout the weeks of pregnancy. Exceptional penile width can also point out a problem with male genitalia. Therefore the investigators wish, as well to establish nomograms of penile width.
- Conditions
- Micropenis
- Keywords
- Penis, Micropenis, Nomograms, Ultrasound, Fetus
- Medical subject headings
- Penis agenesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Penile length
Measured: between 14 and 37 weeks gestation
Penile width
Measured: between 14 and 37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Why it stopped: A similar article was already published by another investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MicropenisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yael Goldberg, MD, Principal investigator, Head of Obstetrics and Gynecologic Ultrasound Unit, The Lady Davis Carmel Medical Center, Affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659528
- Sponsor's protocol ID
- CMC-11-0028-CTIL
- Status last verified
- Jan 2013
- First submitted
- 5 Aug 2012
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Achiron R, Pinhas-Hamiel O, Zalel Y, Rotstein Z, Lipitz S. Development of fetal male gender: prenatal sonographic measurement of the scrotum and evaluation of testicular descent. Ultrasound Obstet Gynecol. 1998 Apr;11(4):242-5. doi: 10.1046/j.1469-0705.1998.11040242.x.
PubMed 9618845Feldman KW, Smith DW. Fetal phallic growth and penile standards for newborn male infants. J Pediatr. 1975 Mar;86(3):395-8. doi: 10.1016/s0022-3476(75)80969-3.
PubMed 1113226Aaronson IA. Micropenis: medical and surgical implications. J Urol. 1994 Jul;152(1):4-14. doi: 10.1016/s0022-5347(17)32804-5. No abstract available.
PubMed 8201683Toppari J, Kaleva M, Virtanen HE. Trends in the incidence of cryptorchidism and hypospadias, and methodological limitations of registry-based data. Hum Reprod Update. 2001 May-Jun;7(3):282-6. doi: 10.1093/humupd/7.3.282.
PubMed 11392374
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy - A Prospective Descriptive Study.
- ClinicalTrials.gov ID
- NCT01659528
- Acronym / sponsor ID
- CMC-11-0028-CTIL
- Conditions
- Micropenis
- Keywords
- Penis, Micropenis, Nomograms, Ultrasound, Fetus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: A similar article was already published by another investigator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 7 Aug 2012 (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.
The purpose of this study is to establish nomograms of penile length and width throughout the weeks of pregnancy.
Detailed description
Identifying pathology of male genitalia is important. It can be an isolated pathology, or connected to disorders in other organs, as part of genetic syndromes or endocrine disorders. Micropenis is a disorder, which is important to diagnose in the womb. Micropenis is defined as a penis which is measured 2.5 standard deviation below average. It is also thinner by diameter. This finding can also be the first expression of a lethal hormonal deficiency, hence the reason for early detection by ultrasound during pregnancy.
Past prenatal diagnosis ultrasound studies, measured the penis from the scrotum to the tip of the penis. Another study evaluated formalin fixated fetuses after pregnancy terminations, in which the penis was measured from the abdominal wall to the tip of the penis. To date there are no nomograms for penile length, via ultrasound measurement from abdominal wall or for penile width. The investigators assume that measuring the penis from the abdominal wall is more accurate and standard than from the end of the scrotum, which is a less definitive reference point.
The investigators aim to establish nomograms of penile length throughout the weeks of pregnancy. Exceptional penile width can also point out a problem with male genitalia. Therefore the investigators wish, as well to establish nomograms of penile width.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women addressing for routine ultrasound scan at the ultrasound unit.
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Proper pregnancy dating
- Normal fetal anatomical scan
- Gestational age 14 to 37 weeks
- Women aged 18 to 50
Key exclusion criteria (5 listed)
- Multiple pregnancy
- Gestational age under 14 or above 37 weeks
- Fetus Small or Large for gestational age
- Abnormal anatomical scan or women who didn't perform such scan
- Minors
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
Penile length
Time frame: between 14 and 37 weeks gestation
Penile width
Time frame: between 14 and 37 weeks gestation
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 1 Feb 2013.
- Background: PubMed 9618845Achiron R, Pinhas-Hamiel O, Zalel Y, Rotstein Z, Lipitz S. Development of fetal male gender: prenatal sonographic measurement of the scrotum and evaluation of testicular descent. Ultrasound Obstet Gynecol. 1998 Apr;11(4):242-5. doi: 10.1046/j.1469-0705.1998.11040242.x.
- Background: PubMed 1113226Feldman KW, Smith DW. Fetal phallic growth and penile standards for newborn male infants. J Pediatr. 1975 Mar;86(3):395-8. doi: 10.1016/s0022-3476(75)80969-3.
- Background: PubMed 8201683Aaronson IA. Micropenis: medical and surgical implications. J Urol. 1994 Jul;152(1):4-14. doi: 10.1016/s0022-5347(17)32804-5. No abstract available.
- Background: PubMed 11392374Toppari J, Kaleva M, Virtanen HE. Trends in the incidence of cryptorchidism and hypospadias, and methodological limitations of registry-based data. Hum Reprod Update. 2001 May-Jun;7(3):282-6. doi: 10.1093/humupd/7.3.282.
Related trials for Micropenis
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Kallmann Syndrome, Hypogonadotropic Hypogonadism
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.
Yael Goldberg, MD principal investigator
Head of Obstetrics and Gynecologic Ultrasound Unit, The Lady Davis Carmel Medical Center, Affiliated with the Rappaport Faculty of Medicine, Technion, Haifa, Israel
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 Micropenis, run by Carmel 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 5 inclusion and 5 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 1 Feb 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.
What does the primary outcome measure?
Penile length (time frame: between 14 and 37 weeks gestation). The study lists 2 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 NCT01659528, which also lists 4 linked publications.
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 1 Feb 2013.