Protocol - Difficulty Getting Pregnant - Retrospective Assessment
- Current Contraception Use - Female
- Current Contraception Use - Male
- Prostate Symptoms
- Removal of Female Reproductive Organs
- Reproductive History - Female
- Reproductive History - Male
Description
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.
Specific Instructions
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.
The Sickle Cell Disease Genitourinary Working Group notes that following fertility across time is not sufficient to establish infertility. Investigators are encouraged to review the current definition for infertility from American Society for Reproductive Medicine. Additionally, the Sickle Cell Disease Genitourinary Working Group notes that infertility is not well understood in participants with sickle cell disease and that the definition and rates of infertility in sickle cell disease may differ from the general population.
Availability
Protocol
1) Was this pregnancy planned?
0[ ]No
1[ ]Yes GO TO Q2
2) How many months did it take you to get pregnant?
_____ months
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?
0[ ]No
1[ ]Yes
Personnel and Training Required
None
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 Category | Required |
|---|---|
| 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
Interviewer-administered questionnaire
Lifestage
Adolescent, Adult
Participants
Women aged 18 to 39
Selection Rationale
These approaches were chosen to reflect the most modern widely accepted methods of measuring time to pregnancy.
Language
English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| Human Phenotype Ontology | Infertility | HP:0000789 | HPO |
| caDSR Form | PhenX PX100404 - Difficulty Getting Pregnant Retrospective Assessment | 6910392 | caDSR Form |
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 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
Source
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.
General References
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.
Protocol ID
100404
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX100404_Difficulty_Getting_Pregnant_Retrospective_Assessment_Month | ||||
| PX100404020000 | How many months did it take you to get pregnant? | N/A | ||
| PX100404_Difficulty_Getting_Pregnant_Retrospective_Assessment_Not_Pregnant | ||||
| PX100404030000 | Has there ever been a time in your life more | N/A | ||
| PX100404_Difficulty_Getting_Pregnant_Retrospective_Assessment_Planned | ||||
| PX100404010000 | Was this pregnancy planned? | N/A | ||
Measure Name
Difficulty Getting Pregnant
Release Date
April 11, 2017
Definition
Methods to assess the length of time that male and female partners have been trying to get pregnant.
Purpose
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.
Keywords
Reproductive health, infertility, pregnancy, Pregnancy Study Online, PRESTO, subfertility, impaired fecundity
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 100402 | Difficulty Getting Pregnant - Current Duration |
| 100403 | Difficulty Getting Pregnant - Prospective Assessment |
| 100404 | Difficulty Getting Pregnant - Retrospective Assessment |
Publications
There are no publications listed for this protocol.