Protocol - Reproductive History - Male
The male participant is asked whether he has ever fathered a pregnancy. For each pregnancy he reports, he is asked his age at the time, whether the pregnancy was planned, and the birth outcome.
If the participant answers "no" to question 1, the protocol is deemed complete.
Below is a definition from the Mayo Clinic website that may assist researchers in using the Toolkit:
Ectopic pregnancy: Pregnancy begins with a fertilized egg. Normally, the fertilized egg attaches itself to the lining of the uterus. With an ectopic pregnancy, the fertilized egg implants somewhere else. An ectopic pregnancy nearly always occurs in one of the tubes that carry eggs from the ovaries to the uterus (fallopian tubes). This type of ectopic pregnancy is known as a tubal pregnancy. Rarely, an ectopic pregnancy occurs in the abdomen, ovary, or neck of the uterus (cervix).
(Mayo Clinic, http://www.mayoclinic.com/health/ectopic-pregnancy/DS00622, accessed February 15, 2010.)
1. Have you ever fathered a pregnancy, regardless of outcome?
[ ] Yes
[ ] No (go to end)
2. If yes, how many?
[ ] Number
3. How old were you when you fathered this pregnancy? (years)
[ ] Years
4. Was this a planned pregnancy? (e.g., you and your partner had intended to get pregnant)
[ ] Yes
[ ] No (skip to question 6)
5. If yes, how many months did it take for your partner to achieve pregnancy?
[ ] Number of months
6. Was this a multiple pregnancy? (e.g., twins, triplets, etc.)
[ ] Yes
[ ] No (skip to question 8)
7. If yes, specify number of fetuses.
[ ] Number
8. What was the outcome of this pregnancy? (NOTE: If multiple birth, repeat question for each fetus. Number the questions 8A, 8B, 8C, etc. as appropriate.)
[ ] Live Birth
[ ] Miscarriage
[ ] Stillbirth
[ ] Abortion
[ ] Ectopic/tubal
[ ] Molar Pregnancy
9. Date of birth or loss ____
Personnel and Training Required
The Longitudinal Investigation of Fertility and the Environment (LIFE) Study is an interviewer-administered survey. The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews. The interviewer should be trained to prompt participants further if a "don’t know" response is provided.
Pencil and paper
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Participants in the Longitudinal Investigation of Fertility and the Environment (LIFE) Study are couples of childbearing age.
The Longitudinal Investigation of Fertility and the Environment (LIFE) Study asks males a comprehensive set of questions regarding their pregnancy history.
|caDSR Common Data Elements (CDE)||Person Reproductive History||3007491||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Reproductive History - male||63071-5||LOINC|
Process and Review
The Expert Review Panel #5 (ERP 5) reviewed the measures in the Reproductive Health domain.
Guidance from ERP 5 includes:
· No significant changes to measure
Back-compatible; no changes to the Data Dictionary.
Protocol Name from Source
The Longitudinal Investigation of Fertility and the Environment (LIFE) Study
Eunice Kennedy Shriver National Institute of Child Health and Human Development. (2005). The Longitudinal Investigation of Fertility and the Environment (LIFE) Study. Rockville, MD: Author. Male Questionnaire. Male Reproductive History, Question 2; Male Pregnancy History, Questions 1-3.
Eunice Kennedy Shriver National Institute of Child Health and Human Development. (2005). The Longitudinal Investigation of Fertility and the Environment (LIFE) Study. Rockville, MD: Author. https://www.nichd.nih.gov/about/org/diphr/od/research/pages/longitudinal.aspx
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX101302090000||Date of birth or loss.||Variable Mapping|
|PX101302030000||How old were you when you fathered this pregnancy?||N/A|
|PX101302010000||Have you ever fathered a pregnancy, more||N/A|
|PX101302020000||How many times have you fathered a more||N/A|
|PX101302070000||Specify number of fetuses.||Variable Mapping|
|PX101302060000||Was this a multiple pregnancy? (e.g. twins, more||Variable Mapping|
|PX101302040000||Was this a planned pregnancy? (e.g. you and more||N/A|
|PX101302050000||How many months did it take for your partner more||N/A|
|PX101302080100||What was the outcome of this pregnancy?||Variable Mapping|
|PX101302080200||What was the outcome of this pregnancy?||Variable Mapping|
|PX101302080300||What was the outcome of this pregnancy?||Variable Mapping|
|PX101302080400||What was the outcome of this pregnancy?||Variable Mapping|
February 26, 2010
Question to assess both males’ and females’ pregnancy history. Females are asked about the number of pregnancies, description of pregnancies, and smoking during pregnancy. Males are asked whether they have ever fathered a pregnancy and, if so, the description of the pregnancy.
The purpose of this measure is to assess the demonstrated fecundity and fertility of the individual. This measure can also be used for estimating certain in utero exposures if the research subject is an infant.
Reproductive health, pregnancy history, pregnancy outcomes, Women’s Interview Study of Health, WISH, Pregnancy Risk Assessment Monitoring System, PRAMS, Longitudinal Investigation of Fertility and the Environment Study, LIFE Study