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

Micropenis Clinical Trial

Official title:

Establishing Nomograms of Penile Length and Width Throughout the Weeks of Pregnancy - A Prospective Descriptive Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01659528
• Other study ID #: CMC-11-0028-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: August 5, 2012
• Last updated: January 31, 2013
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2013
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to establish nomograms of penile length and width throughout the weeks of pregnancy.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy

• Proper pregnancy dating

• Normal fetal anatomical scan

• Gestational age 14 to 37 weeks

• Women aged 18 to 50

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Micropenis

Locations

Country	Name	City	State
Israel	OBGYN Ultrasound Unit, Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (4)

Aaronson IA. Micropenis: medical and surgical implications. J Urol. 1994 Jul;152(1):4-14. Review. — View Citation

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. — View Citation

Feldman KW, Smith DW. Fetal phallic growth and penile standards for newborn male infants. J Pediatr. 1975 Mar;86(3):395-8. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penile length		between 14 and 37 weeks gestation	No
Primary	Penile width		between 14 and 37 weeks gestation	No