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Can the Hypertrophy of Contralateral Testis Predict the Absence of the Non-palpable Testis in the Boys Aged From 6months to 18months of Age ?

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ClinicalTrials.gov Identifier: NCT02203318
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The aim of this study is to verify whether the hypertrophy of contralateral testis may predict the absence of the non-palpable testis in the boys younger than 24months of age. According to the previous studies of other countries, the large size of the contralateral testis of the nonpalpable testis has positive correlation woth the weak viability of the affected testis. We are going to evaluate this hypothesis with prospective study. 3 groups are going to be enrolled into this study ; non-palpable testis group(Group1), palpable but not normally descended testis group(group2) and control group(group3). The size of testis will be measured with Ultrasound and the length, width and the height will be measured before surgery at outpatient department. For the group 1 & 2, the viability of the affected testis will be evaluated and compared after surgery. In addition the comparison with normal control group is also going th be conducted.

Condition or disease
Focus of Study

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Group/Cohort
control
healthy children with normal bilateral testis
undescended palpable testis
patient whose affected testis is not descended to the normal position but palpable and exist intact in the upper area
non-paplpable testis
patient whose affected testis is not palpable during the physical examination



Primary Outcome Measures :
  1. Size of contralateral testis [ Time Frame: 1 day of initial visit ]
    The testicular size is measured 3-dimensionally with ultrasonography. The length, width and height will be measured and the volume of testis will be evaluated.



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Ages Eligible for Study:   6 Months to 18 Months   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
totally, 72 children : unpalpable testis : 24 children, palpable undescended testis : 24 children, normal control : 24 children
Criteria

Inclusion Criteria:

  1. neonates or Infants who visited the out-patient clinic with nonpalpable or undescended testis.(group 1, 2) aged from 6months to 18months
  2. neonates or Infants aged from 6months to 18months with normal testis (volunteers, Group3)

Exclusion Criteria:

  1. previous history of hormonal therapy.
  2. chromosomal abnormality
  3. previous history of abdomen or inguinal area surgery
  4. children diagnosed with epididymitis or orchitis
  5. twin baby
  6. infants with premature (<37 weeks) birth history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203318


Locations
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Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02203318    
Other Study ID Numbers: 4-2014-0385
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Yonsei University:
cryptorchidism, undescended testis, hypertrophy of contralateral testis
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical