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Protocol - Male Reproductive Tract Birth Defects

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Description:

The male participant answers whether he was ever diagnosed with Cryptorchidism, Hypospadias and/or other related conditions.

Specific Instructions:

The questions were originally asked of partners of pregnant women but the WG recommends asking them of adult males.

Note: Cryptorchidism is failure of one or both of the testes to descend into the scrotum. Hypospadias is a developmental anomaly in which the male urethra opens on the underside of the penis or on the perineum.

Protocol:

1. Were you born with one or both of your testicles undescended (not completely down in the scrotum)?

[ ] 0 No (go to 5)

[ ] 1 Yes

[ ] 2 Don’t know (go to 5)

2. If yes, which testicle was this?

[ ] a Right

[ ] b Left

[ ] c Both

3. Did the testicle go down to the scrotum by itself?

[ ] 0 No

[ ] 1 Yes

[ ] 2 Don’t know

4. Did you receive treatment?

[ ] 0 No

[ ] 1 Yes

[ ] 2 Don’t know

5. What treatment?

[ ] Surgery

[ ] Hormones

[ ] Other (specify)

[ ] Don’t know

6. Has your doctor or another health care provider ever told you that you had other diseases of the penis, testicles, urinary tract or scrotum (specify)?

___________

7. Has your doctor or another health care provider ever told you that you had hypospadias?

[ ] No

[ ] Yes

8. What was your most recent treatment or medication (if any)?

[ ] Specify

[ ] Don’t Know

[ ] Year

Protocol Name from Source:

Study For Future Families

Availability:

Publicly available

Personnel and Training Required

None

Equipment Needs

Paper and pencil

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Self-administered questionnaire

Life Stage:

Adult

Participants:

Males 18-53

Selection Rationale

The presence of these physical conditions is often associated with abnormalities of androgen production such as Kallmann’s Syndrome and 5 alpha reductase deficiency, and may be associated with certain chemical exposures in utero. The Study for Future Families’ protocol was selected because it specifically addresses physical exam findings.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Male Reproductive System Birth Defect 3007471 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Male reproductive birth defects proto 62664-8 LOINC
Derived Variables

None

Process and Review

The Expert Review Panel #5 (ERP 5) reviewed the measures in the Reproductive Health domain.

Guidance from ERP 5 includes:

· Revised descriptions of the measure

  • Spelling of hypospadias corrected throughout measure

Back-compatible: there are changes to the Data Dictionary, previous version of the Data Dictionary and Variable mapping in Toolkit archive (link)

Source

Swan, S.H., Brazil, C., Drobnis, E.Z., Liu, R.L., Hatch, M., Redmon, J.B., Wang, C., Overstreet, J.M., (2003). Geographic Differences in Semen Quality of Fertile U.S. Males. Environmental Health Perspectives, 111(4): 414-420. Utilizes questionnaire generated by the Study For Future Families

General References

Swan, S.H., Main, K.M., Liu, F., Stewart, S.L., Kruse, R.L., Calafat, A.M., et al; Study for Future Families Research Team. (2005). Decrease in anogenital distance among male infants with prenatal phthalate exposure. Environ Health Perspect., 113(8):1056-61.

Protocol ID:

100901

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX100901_Male_Reproductive_Tract_Birth_Defects_Medical_Diagnosis_Hypospadias PX100901070000 Has your doctor or another health care provider ever told you that you had hypospadias? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Medical_Diagnosis_Penis_Scotum_Urinary_Tract_Testicles PX100901060000 Has your doctor or another health care provider ever told you that you had other diseases of the penis, testicles, urinary tract or scrotum (specify)? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Recent_Treatment PX100901080100 What was your most recent treatment or medication (if any)? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Recent_Treatment_Encoded PX100901080200 What was your most recent treatment or medication (if any)? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Recent_Treatment_Year PX100901080300 What was your most recent treatment or medication (if any)? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Testicles_Undescended PX100901010000 Were you born with one or both of your testicles undescended (not completely down in the scrotum)? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Testicles_Undescended_Specify PX100901020000 If yes, which testicle was this? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Testicle_Scrotum PX100901030000 Did the testicle go down to the scrotum by itself? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Treatment PX100901040000 Did you receive treatment? N/A
PX100901_Male_Reproductive_Tract_Birth_Defects_Treatment_Type PX100901050000 What treatment? N/A
Reproductive Health
Measure Name:

Male Reproductive Tract Birth Defects

Release Date:

April 11, 2017

Definition

Questions to determine whether a male participant has ever had certain conditions that could have developed in utero. Cryptorchidism is failure of one or both of the testes to descend into the scrotum. Hypospadias is a developmental anomaly in which the male urethra opens on the underside of the penis or on the perineum.

Purpose

The purpose of these questions is to determine whether the participant had ever had the following abnormalities that developed in utero: Cryptorchidism, Hypospadias, and/or other related conditions. These conditions are suspected of being hereditary and/or influenced by environmental factors, may reflect abnormalities of androgen production, and may be passed to offspring.

Keywords

Reproductive health, male reproductive tract birth defects, male in utero conditions, Cryptorchidism, Hypospadias, penis, testicles, urinary tract