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WithdrawnNCT01659528Updated Feb 1, 2013

Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy

An observational study in Micropenis, sponsored by Carmel Medical Center. Withdrawn at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-01.

Sponsored by Carmel Medical Center · Observational

Why this study was withdrawn
A similar article was already published by another investigator.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 50 Years
Sex
Female
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Study summary

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.

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Conditions studied

  • Micropenis

Keywords

  • Penis
  • Micropenis
  • Nomograms
  • Ultrasound
  • Fetus
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In context

Lead sponsor

Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant women addressing for routine ultrasound scan at the ultrasound unit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Singleton pregnancy
  • Proper pregnancy dating
  • Normal fetal anatomical scan
  • Gestational age 14 to 37 weeks
  • Women aged 18 to 50

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
06

What researchers measure

Primary outcomes

  1. Penile length

    Time frame: between 14 and 37 weeks gestation

  2. Penile width

    Time frame: between 14 and 37 weeks gestation

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Study locations

1 site
  • OBGYN Ultrasound Unit, Carmel Medical Center
    Haifa, Israel, Israel
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References and documents

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 9618845 ↗
  • Feldman 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 1113226 ↗
  • Aaronson 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 8201683 ↗
  • Toppari 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 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2012, a primary completion of Jul 2014 and a completion of Jul 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2012
First posted
Aug 7, 2012
Start
Jul 2012
Primary completionEst.
Jul 2014
CompletionEst.
Jul 2014
Last update
Feb 1, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01659528
Lead sponsor
Carmel Medical Center
Responsible party
Sponsor
First posted
Aug 7, 2012
Start date
Jul 2012
Primary completion
Jul 2014 (estimated)
Completion
Jul 2014 (estimated)
Last update
Feb 1, 2013

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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