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An internet-based preconception cohort study in North America

Award Number: R01HD086742
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/14/2016
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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An internet-based preconception cohort study in North America - ABSTRACT About 15% of American couples experience infertility (time-to-pregnancy >12 months) and more than 20% of couples experience spontaneous abortion (SAB, pregnancy loss <20 weeks of gestation). Fertility treatment is costly and inaccessible to most Americans, particularly people of color and low-income individuals. Among those with access to treatment, fertility treatment has relatively low success rates and is associated with adverse perinatal outcomes. There are also large racial/ethnic disparities in treatment success rates. As infertility and SAB exact an emotional and financial toll on affected couples, identifying modifiable risk factors for these outcomes in both partners is an important public health goal. With previous support from the NICHD, we designed a web-based prospective cohort study to recruit, follow, and collect comprehensive data on couples attempting pregnancy. Some of our strongest findings to date pertain to poor sleep quality and stress in both partners. To build on this work, we are submitting a renewal application (R01-HD086742) to evaluate the influence of understudied sleep- and stress-related exposures on subfertility and SAB risk, explore putative mechanisms of effect, and examine the extent to which these factors explain existing race/ethnic disparities in subfertility and SAB. Pregnancy Study Online (PRESTO) is a web-based preconception cohort study in North America that has enrolled more than 16,000 females and nearly 4,000 male partners during the preconception period, with 20% of PRESTO participants identifying as Black, Indigenous, or People of Color (BIPOC). In this renewal application, we propose to enroll an additional 8,000 females to enhance power for more detailed analyses of sleep using the Pittsburgh Sleep Quality Index, selected stressors (e.g., childhood adversity, discrimination, financial hardship, COVID-related factors), and risk of subfertility and SAB. We also propose to collect and analyze more objective exposure data using sleep actigraphy (Fitbit Inspire 2) and stress biomarkers (hair cortisol and salivary alpha-amylase) in a subset of new participants. We will enroll an additional 2,000 male partners to enhance power for examining male exposures and joint effects in both partners. To ensure power for key hypotheses (e.g., reproductive effects of racial discrimination), we will oversample BIPOC participants. This renewal application builds on our previous work indicating that stress and sleep quality are important determinants of reproductive health. Our expanded focus on understudied stressors—in populations that are underrepresented in reproductive and perinatal research (e.g., males and BIPOC)—is novel and of high public health importance. Preconception enrollment minimizes misclassification, selection bias, and reverse causation, and captures early SABs (<8 weeks of gestation), a priority area for NICHD. The cohort’s prospective design, cost-efficient web- based infrastructure for participant recruitment and follow-up, geographic and racial/ethnic heterogeneity, and comprehensive collection of confounder data in both partners are added strengths. Results will generate data that can inform public health interventions to reduce the population burden of subfertility and SAB.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $652,922 )
2025	2025	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	9	4/15/2025	NON-COMPETING CONTINUATION	$652,922
														Subtotal = $652,922

Issue Date FY: 2024 ( Subtotal = $669,310 )
2024	2024	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	8	5/14/2024	NON-COMPETING CONTINUATION	$669,310
														Subtotal = $669,310

Issue Date FY: 2023 ( Subtotal = $678,744 )
2023	2023	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	002	7	5/22/2023	NON-COMPETING CONTINUATION	$678,744
2023	2022	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	6	3/28/2023	COMPETING CONTINUATION	$311
2023	2021	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	5	3/28/2023	SUPPLEMENT FOR EXPANSION	-$311
														Subtotal = $678,744

Issue Date FY: 2022 ( Subtotal = $708,812 )
2022	2022	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	6	8/9/2022	COMPETING CONTINUATION	$708,812
														Subtotal = $708,812

Issue Date FY: 2021 ( Subtotal = $299,328 )
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	5	9/15/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	5	8/27/2021	SUPPLEMENT FOR EXPANSION	$299,328
														Subtotal = $299,328

Issue Date FY: 2020 ( Subtotal = $661,483 )
2020	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	5	6/17/2020	NON-COMPETING CONTINUATION	$563,280
2020	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	002	5	9/24/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	5	9/16/2020	SUPPLEMENT FOR EXPANSION	$98,203
														Subtotal = $661,483

Issue Date FY: 2019 ( Subtotal = $591,929 )
2019	2019	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	4	7/22/2019	NON-COMPETING CONTINUATION	$543,179
2019	2019	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	004	4	8/12/2019	NON-COMPETING CONTINUATION	$25,251
2019	2018	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	003	3	8/12/2019	NON-COMPETING CONTINUATION	$13,534
2019	2017	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	002	2	8/12/2019	NON-COMPETING CONTINUATION	$9,965
2019	2016	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	001	1	8/12/2019	NEW	$0
														Subtotal = $591,929

Issue Date FY: 2018 ( Subtotal = $571,528 )
2018	2018	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	3	5/29/2018	NON-COMPETING CONTINUATION	$571,528
														Subtotal = $571,528

Issue Date FY: 2017 ( Subtotal = $583,336 )
2017	2017	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	2	6/9/2017	NON-COMPETING CONTINUATION	$583,336
														Subtotal = $583,336

Issue Date FY: 2016 ( Subtotal = $622,159 )
2016	2016	BOSTON UNIVERSITY	25 BUICK ST	BOSTON	MA	02215	SUFFOLK	USA	Child Health and Human Development Extramural Research	000	1	9/14/2016	NEW	$622,159
														Subtotal = $622,159

Grand Total All Awards = $6,039,551

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An internet-based preconception cohort study in North America

Award Number: R01HD086742

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/14/2016

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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