Protocol - Difficulty Getting Pregnant - Retrospective Assessment
Depending on the aims of the project and feasibility, there are three widely used methods to assess difficulty getting pregnant or impaired fecundity. These include: retrospective assessment, prospective assessment, and the current duration approach.
For the retrospective approach (also the approach used for cross-sectional studies), women or couples are asked if the pregnancy was planned and, if yes, how many months it took to get pregnant. It is important to note that this approach can only be used with women or couples who planned their pregnancies.
For prospective assessment, women or couples are followed over time as they try to get pregnant. Women or couples are asked to record exposure data, menstrual cycle data, intercourse, and pregnancy status prospectively over time. Again, this method can only be employed with women or couples who are planning a pregnancy.
If investigators are interested in exposures among women or couples who are not planning a pregnancy, the current duration approach can be used. For this approach, women or couples are asked about the date that they last used contraception.
The PhenX Expert Review Panel recommends this question be asked of either men or women, ages 15 and older with confirmed pregnancy.
The referenced publication, Slama et al. (2014), indicates that the questions can be slightly amended for men.
1) Was this pregnancy planned?
1[ ]Yes GO TO Q2
2) How many months did it take you to get pregnant?
3) Has there ever been a time in your life during which you didn’t become pregnant despite 12 or more months of regular unprotected intercourse?
Personnel and Training Required
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.
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Women aged 18 to 39
These approaches were chosen to reflect the most modern widely accepted methods of measuring time to pregnancy.
|caDSR Common Data Elements (CDE)||Person Retrospective Assessment Conception Difficulty Assessment Description Text||5720247||CDE Browser|
|Human Phenotype Ontology||Infertility||HP:0000789||HPO|
Process and Review
The Expert Review Panel #5 (ERP 5) reviewed the measures in the Reproductive Health domain.
Guidance from ERP 5 includes the following:
· Changed the name of the measure
· New protocol
· New Data Dictionary
Protocol Name from Source
Slama, R., et al, Epidemiologic tools to study the influence of environmental factors on fecundity and pregnancy-related outcomes, EPIDEMIOL REVs, 2014
Slama, R., Ballester, F., Casas, M., Cordier, S., Eggesbø, M., Iniguez, C., Nieuwenhuijsen, M., Philippat, C., Rey, S., Vandentorren, S., & Vrijheid, M. (2014). Epidemiologic tools to study the influence of environmental factors on fecundity and pregnancy-related outcomes. Epidemiologic Reviews, 36, 148-164.
Buck Louis, G. M., Schisterman, E. F., Sweeney, A. M., Wilcosky, T. C., Gore-Langton, R. E., Lynch, C. D., Boyd Barr, D., Schrader, S. M., Kim, S., Chen, Z., & Sundaram, R.; LIFE Study. (2011). Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development-The LIFE Study. Paediatric and Perinatal Epidemiology, 25(5), 413-424.
Nguyen, R. H., & Baird, D. D. (2005). Accuracy of men’s recall of their partner’s time to pregnancy. Epidemiology, 16(5), 694-698.
Slama, R., Ballester, F., Casas, M., Cordier, S., et al. (2014). Epidemiologic tools to study the influence of environmental factors on fecundity and pregnancy-related outcomes. Epidemiologic Reviews, 36, 148-164.
Tingen, C., Stanford, J. B., & Dunson, D. B. (2004). Methodologic and statistical approaches to studying human fertility and environmental exposure. Environmental Health Perspectives, 112(1), 87-93.
Weinberg, C. R., Baird, D. D., & Wilcox, A. J. (1994). Sources of bias in studies of time to pregnancy. Statistics in Medicine, 13(5-7), 671-681.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX100404020000||How many months did it take you to get pregnant?||N/A|
|PX100404030000||Has there ever been a time in your life more||Variable Mapping|
|PX100404010000||Was this pregnancy planned?||N/A|
Difficulty Getting Pregnant
April 11, 2017
Methods to assess the length of time that male and female partners have been trying to get pregnant.
These methods ascertain whether a person and his or her partner are trying to become pregnant and how long they have been trying. Difficulty in conceiving may have genetic or epigenetic origins and is also related to lifestyle and environmental exposures.
Reproductive health, infertility, pregnancy, Pregnancy Study Online, PRESTO, subfertility, impaired fecundity