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Protocol - Reproductive History - Male

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Protocol Name from Source:

The Longitudinal Investigation of Fertility and the Environment (LIFE) Study

Availability:

Publicly available

Description:

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.

Protocol:

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.

Equipment Needs

Pencil and paper

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Adult

Specific Instructions:

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.)

Research Domain Information

Release Date:

April 11, 2017

Definition

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.

Purpose

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.

Selection Rationale

The Longitudinal Investigation of Fertility and the Environment (LIFE) Study asks males a comprehensive set of questions regarding their pregnancy history.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Person Reproductive History3007491CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Reproductive History - male63071-5LOINC

Process and Review

The [link[www.phenx.org/node/110|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.

Source

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.

General References

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

Protocol ID:

101302

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX101302_Father_Pregnancy_EverPX101302010000Have you ever fathered a pregnancy, regardless of outcome?4N/A
PX101302_Father_Pregnancy_TimesPX101302020000How many times have you fathered a pregnancy, regardless of outcome?4N/A
PX101302_Father_Pregnancy_AgePX101302030000How old were you when you fathered this pregnancy?4N/A
PX101302_Planned_PregnancyPX101302040000Was this a planned pregnancy? (e.g. you and your partner had intended to get pregnant)4N/A
PX101302_Planned_Pregnancy_Months_AchievePX101302050000How many months did it take for your partner to achieve pregnancy?4N/A
PX101302_Multiple_Pregnancy_Twins_TripletsPX101302060000Was this a multiple pregnancy? (e.g. twins, triplets, etc.)4Variable Mapping
PX101302_Multiple_Pregnancy_Fetuses_NumberPX101302070000Specify number of fetuses.4Variable Mapping
PX101302_Pregnancy_Outcome_Fetus_1PX101302080100What was the outcome of this pregnancy?4Variable Mapping
PX101302_Pregnancy_Outcome_Fetus_2PX101302080200What was the outcome of this pregnancy?4Variable Mapping
PX101302_Pregnancy_Outcome_Fetus_3PX101302080300What was the outcome of this pregnancy?4Variable Mapping
PX101302_Pregnancy_Outcome_Fetus_4PX101302080400What was the outcome of this pregnancy?4Variable Mapping
PX101302_Birth_Loss_DatePX101302090000Date of birth or loss.4Variable Mapping