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Protocol - Causes and Treatments of Known Infertility - Male

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Protocol Name from Source:

National Survey of Family Growth (NSFG)

Availability:

Publicly available

Description:

The interviewer asks the participant questions about whether the participant or partner has needed medical assistance with having a baby, the type of assistance, and the type of infertility problems.

Protocol:

1. Did you or your partner* ever go/Have you or your partner* ever been to a doctor or other medical care provider to talk about ways to help you have a baby together?

[ ] 1 Yes

[ ] 5 No (Skip to end)

NOTE: Do not code yes if main purpose of visit was for something other than seeking help to have a baby.

2. Which of the services (did/have) you or your/partner*) (have/had) to help you have a baby together? ENTER all that apply:

[ ] 1 Advice

[ ] 2 Infertility testing

[ ] 3 Drugs to improve ovulation

[ ] 4 Surgery to correct blocked tubes

[ ] 5 Artificial insemination

[ ] 6 Treatment for varicocele

[ ] 7 Other types of medical help

3. When you and your partner* went for medical help to have a baby together, were you ever told that you had any of the following male infertility problems? ENTER all that apply:

[ ] 1 Low sperm count or no sperm

[ ] 2 Varicocele

[ ] 3 Genetic disorder that alters sperm production

[ ] 4 Low testosterone level

[ ] 5 Other

[ ] 6 None of the above

*Note: The questions have been modified by the PhenX Working Group to indicate partner instead of wife.

Personnel and Training Required

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

If a computer-assisted instrument is used, computer software may be necessary to develop the instrument. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

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:

Adolescent, Adult

Specific Instructions:

Questions 1-3 are asked of both males and females.

The National Survey of Family Growth (NSFG) provides a card of response categories to the respondent. For example, in question 2, an investigator would provide the respondent with a card listing the categories "advice, infertility testing, drugs to improve ovulation," "surgery to correct blocked tubes," "artificial insemination," "treatment for varicocele," and "other types of medical help." The Expert Review Panel recommends that additional categories be added to question 2 for “donor sperm,” “in-vitro fertilization,” “intracytoplasmic sperm injection,” “testicular sperm retrieval,” and “vasectomy reversal.” For question 3, they recommend revising the first category to “sperm problems” and adding additional categories for “hormone deficiency” and “genetic infertility (e.g., Klinefelter syndrome).” A card was also provided in question 3.

The male NSFG questions (questions 1-3) have been modified to indicate partner instead of wife.

Below is a definition from the Mayo Clinic website that researchers may find helpful in using the toolkit:

  • A varicocele (VAR-ih-koe-seel) is an enlargement of the veins within the scrotum, the loose bag of skin that holds your testicles. A varicocele is similar to a varicose vein that can occur in your leg. Varicoceles are a common cause of low sperm production and decreased sperm quality, although not all varicoceles affect sperm production. Varicoceles also can cause testicles to shrink. (Mayo Clinic. http://www.mayoclinic.com/health/Varicocele/DS00618. Accessed February 15, 2010.)

The PhenX Working Group recommends this measure should be preceded by "Difficulty Getting Pregnant" for a more complete assessment of infertility.

Research Domain Information

Release Date:

April 11, 2017

Definition

Questions to assess a participant’s experience with infertility

Purpose

These questions are used to determine the cause of the participant’s or his or her partner’s infertility and the treatments that he or she may have sought. It is important to measure because it can be related to birth outcomes (e.g., multiple births). Infertility may also be associated with gene/environmental interactions.

Selection Rationale

The National Survey of Family Growth (NSFG) 2013-2015 includes questions that address the causes and treatment of infertility. The survey includes both male and female respondents and represents the household population of the United States aged 15-44 years.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Male Known Infertility Reason Assessment Description Text3007421CDE Browser

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 the following:

· Updated protocol

· New Data Dictionary

Back-compatible: there are changes to the Data Dictionary, previous version of the Data Dictionary and Variable mapping in Toolkit archive ([link[www.phenxtoolkit.org/index.php?pageLink=browse.archive.protocols&id=100000|link]])

Source

Centers for Disease Control and Prevention (CDC). National Survey of Family Growth (NFSG) Staff Division of Vital Statistics, National Center for Health Statistics. National Survey of Family Growth (NSFG) 2013-2015 Male. Questions INFHELP IE-1 (question 1), INFSVCS IE-2 (question 2), NSFG INFRTHIS IE-7 (question 3).

General References

Lepkowski, J. M., Mosher, W. D., Davis, K. E., Groves, R. M., van Hoewyk, J., & Willem, J. (2006). National Survey of Family Growth, Cycle 6: Sample design, weighting, imputation, and variance estimation. Vital Health Statistics, 2(142), 1-82.

Martinez, G. M., Chandra, A., Abma, J. C., Jones, J., & Mosher, W. D. (2006). Fertility, contraception, and fatherhood: Data on men and women from cycle 6 (2002) of the 2002 National Survey of Family Growth. Vital Health Statistics, 23(26), 1-142.

Protocol ID:

100203

Variables:

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Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping