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Study Title and Description

Caffeinated and alcoholic beverage intake in relation to ovulatory disorder infertility.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on reproductive and developmental outcomes?
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Primary Publication Information
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TitleData
Title Caffeinated and alcoholic beverage intake in relation to ovulatory disorder infertility.
Author JE Chavarro,JW Rich-Edwards,BA Rosner,WC Willett,
Country
Year 2009
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Reproductive Toxicity - Design Details
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 19279491
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What outcome is being evaluated in this paper? Reproductive and Development
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What is the objective of the study (as reported by the authors)? Although clear pathophysiologic mechanisms for the purported effects of caffeine and alcohol on fertility have not been elucidated, both substances have been suggested to affect ovulation. However, caffeine and alcohol intake have both been linked to improved insulin sensitivity, which in turn has been related to improved ovulatory function in women with polycystic ovary syndrome. Polycystic ovary syndrome is the most common cause of anovulation in women of reproductive age, and the most common cause of infertility due to ovulation disorders. Moreover, neither caffeine nor alcohol intake is related to biologic markers of ovarian aging. To investigate these associations, we prospectively evaluated whether intake of alcohol, caffeine, or specific alcoholic and caffeinated beverages were associated with the risk of infertility due to ovulatory disorders in a large group of apparently healthy women.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) Female registered nurses ages 24–42 were followed; 18,555 married women without a history of infertility for 8 years as they attempted to become (or became) pregnant. Diet was measured twice during this period and prospectively related to the incidence of ovulatory disorder infertility. On biennial questionnaires participants were asked whether they had tried to become pregnant for more than 1 year without success since the previous questionnaire administration, and whether their inability to conceive was caused by tubal blockage, ovulatory disorder, endometriosis, cervical mucus factor, spousal factor, or reasons. (Other options were no investigation of causes, and no cause discovered.) In a validation substudy, self-reported diagnosis of ovulatory disorder infertility was confirmed by review of medical records in 95% of the cases In each follow-up questionnaire, women were asked if they became pregnant during the preceding 2-year period (including pregnancies resulting in miscarriages or induced abortions). Only married women, with available dietary information and without a history of infertility (defined as a report of infertility in any preceding questionnaire), were eligible to enter the analysis. Dietary information was collected in 1991 and 1995 using a food-frequency questionnaire (FFQ) with more than 130 food items, including 14 caffeinated or alcoholic beverages (eAppendix, http://links.lww.com). Participants were asked to report how often, on average, they consumed each of the foods and beverages included in the FFQ during the previous year. The questionnaire offered 9 options for frequency of intake, ranging from never or less than once per month to 6 or more times per day. Relative risks relating intakes of caffeine, alcohol, and specific beverages to the incidence of ovulatory disorder infertility were estimated using logistic regression. Analyses were performed using the most recent intakes and cumulative averaged intakes; the results from these 2 methods were nearly identical. All models were adjusted for total energy intake, age, and calendar time at the beginning of each questionnaire cycle. Multivariate models included additional terms for parity, body mass index (wt [kg]/ht2 [m2 ]) (BMI), smoking history, physical activity, history of oral contraceptive use, and a summary diet score that incorporated multiple dietary factors previously found to be related to infertility due to ovulation disorders in this population. Multivariate models were also adjusted for alcohol.
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How many outcome-specific endpoints are evaluated? 1
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) ovulatory disorder infertility
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes
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Clinical Clinical
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Physiological
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Other
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What is the study design? Cohort
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Both
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Optional: Name of Method or short description On biennial questionnaires participants were asked whether they had tried to become pregnant for more than 1 year without success since the previous questionnaire administration, and whether their inability to conceive was caused by tubal blockage, ovulatory disorder, endometriosis, cervical mucus factor, spousal factor, or reasons. (Other options were no investigation of causes, and no cause discovered.) In a validation substudy, self-reported diagnosis of ovulatory disorder infertility was confirmed by review of medical records in 95% of the cases.
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda Soda
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Tea Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults Adults
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Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) Caffeine mg/day: </=30, 31-82, 83-160, 161-332, >/=333
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) All models were adjusted for total energy intake, age, and calendar time at the beginning of each questionnaire cycle. Multivariate models included additional terms for parity, body mass index (wt [kg]/ht2 [m2 ]) (BMI), smoking history, physical activity, history of oral contraceptive use, and a summary diet score that incorporated multiple dietary factors previously found to be related to infertility due to ovulation disorders in this population. Multivariate models were also adjusted for alcohol.
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Provide a general description of results (as reported by the authors). Caffeine intake was unrelated to the risk of infertility due to ovulation disorders, as were coffee (the main source of caffeine in this population), decaffeinated coffee, and tea. The multivariate-adjusted relative risk (RR), 95% confidence interval (CI), P for trend comparing the highest to lowest categories of intake were 0.86 (0.61–1.20; 0.44) for total caffeine. However, intake of caffeinated soft drinks was positively related to ovulatory disorder infertility. The multivariate-adjusted RR 95% CI, and P for trend comparing the highest to lowest categories of caffeinated soft drink consumption were 1.47 (1.09–1.98; 0.01). Similar associations were observed for noncaffeinated, sugared, diet and total soft drinks. The multivariate-adjusted RR comparing women consuming coffee more than 4 times per day to women consuming coffee less than once weekly was 0.45 (0.21–0.97) with a statistically significant linear trend (P for trend = 0.05). Similarly, the multivariate-adjusted RR comparing women in the top 5% of the caffeine distribution (median intake 654 mg/day) with women in the bottom 5% (median intake 3 mg/day) was 0.51 (0.27–0.98) although a clear dose–response relationship was not apparent
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Did the authors perform a dose-response analysis (or trend/related analysis)? Yes
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What were the authors's observations re: trend analysis? The multivariate-adjusted relative risk (RR), 95% confidence interval (CI), P for trend comparing the highest to lowest categories of intake were 0.86 (0.61–1.20; 0.44) for total caffeine
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What were the author's conclusions? In summary, our results do not support the notion that consuming alcohol or caffeine in moderation affects ovulatory function to the point of increasing the frequency of infertility due to ovulation disorders. Consistent with previous reports, these data also suggest that soft drinks may be a risk factor for infertility and that this relation is independent of their caffeine content. Because a randomized trial of moderate caffeine or alcohol consumption in relation to fertility may be judged as unethical, further large prospective observational studies, preferably in populations with different patterns of alcohol and caffeine use, are necessary to determine whether moderate consumption of these substances affects fertility in humans.
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What were the sources of funding? Supported by CA50385, the main Nurses’ Health Study II grant and by the Yerby Postdoctoral Fellowship Program. The Nurses Health Study II is supported for other specific projects by the following NIH grants: CA55075, CA67262, AG/CA14742, CA67883, CA65725, DK52866, HL64108, HL03804.
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What conflicts of interest were reported? None reported
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  ovulatory disorder infertility NOAEL =>/=333 mg/day caffeine
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. The multivariate-adjusted relative risk (RR), 95% confidence interval (CI), P for trend comparing the highest to lowest categories of intake were 0.86 (0.61–1.20; 0.44) for total caffeine. No significant findings at any intake level.
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What is the importance of the study with respect to the adverseness of the outcome? Critcal
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