Notice Number: NOT-HD-07-009

Key Dates
Release Date:  January 26, 2007

Issued by
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)

The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) intends to solicit proposals from organizations with the requisite capabilities to undertake a longitudinal study to determine empirically if infertility treatments, such as ovulation-stimulating medications and the various assisted reproductive technologies (ART), adversely affect the growth, motor, and social development of children from birth through age three years.  This requirement is defined as code 541710 under the North American Industry Classification Systems (NAICS).

Background

A growing body of scientific evidence suggests that infertility treatment may impact human health and development.  The number of children conceived with the help of infertility treatments currently comprises approximately one – two percent of live births in the United States.  But, the proportion is expected to continue to increase and the characteristics of the women undergoing treatment to change as more States begin to mandate health insurance coverage for infertility and ART procedures and as the efficacy of these therapies continues to improve.  A recent report of the U.S. President's Council on Bioethics called for:  (a) improved monitoring of infertility treatments and outcomes, (b) long-term longitudinal studies to assess child health concerns, and (c) improved/expanded decision-making for parents and practitioners.  Moreover, the Council called attention to the fact that virtually no data exist for populations of such children with regard to their growth and neurodevelopment during infancy and childhood.  Given that a notable portion of children conceived with the help of infertility treatment are born early or growth-restricted, they are a subgroup of children at risk for developmental disabilities, including subtle differences in perception, cognition, vision or motor skills.  These endpoints are in need of systematic, empirical, and longitudinal investigation.

Choice of comparison populations remains an issue for children conceived by infertility treatment or ART, given that the preponderance of literature has relied upon naturally-conceived children (assumed or otherwise).  More appropriate comparison groups, particularly for long-term outcomes among singleton infants, might be children of subfecund couples who become pregnant without ovulation-induction agents or ART.  To ensure sufficient power for a longitudinal follow-up, to have access to a large enough sample of women and outcomes (for comparison at various levels of fertility), and to avoid a lack of generalizability due to the specialized treatment regimens employed at individual clinics, any study attempting to answer questions (i.e., differential loss to follow-up, longitudinal trends, choice of controls) about the long-term consequences of fertility treatment needs to be population-based.  A population-based study is now possible because the revised U.S. Standard Certificate of Live Birth that is being phased in nationally includes a question about the use of infertility treatment in the Prenatal Tests and Procedures section, and that question can be used to identify appropriate children for follow-up.

Objectives

A population-based sampling strategy will be used to recruit, in a ratio of 1:3, a matched-exposure cohort of infants identified from pregnancies conceived with the help of infertility treatment, as noted on birth certificates and children who were conceived without such therapies.  For the primary cohort, a total of 1,500 infants identified on birth certificates as having been conceived by infertility treatment (exposed) are to be enrolled as study subjects at three to five months of age (gestation-corrected, if necessary) and followed longitudinally for three years (until age 36 months), along with the cohort of 4,500 unexposed children, matched for maternal age, zip code of residence, and plurality of birth.  All co-twins (or triplet siblings) of study subjects are also to be enrolled simultaneously and either their outcomes noted (e.g., stillbirth, neonatal mortality) or they are to be followed (secondary cohort) on the same schedule as study subjects.  Assuming that approximately one third of the birth outcomes from infertility treatment are twins or higher order multiples, the secondary cohort is expected to number 2,000 (500 twin siblings of exposed and 1,500 twin siblings of unexposed infants).  The period of recruitment for the cohorts is expected to last 10 months to one year.  The sampling frame for the study is expected to be either a State or consortium of States that have real-time access to birth certificates and adequate numbers of births from infertility treatment to meet study requirements.

Parents will be asked to participate in the study for three years by:  (a) completing an initial questionnaire about the pregnancy, including, for example, confirmation of infertility treatment, time-to-pregnancy, infant feeding, and other demographic and socio-economic factors (i.e., maternal education, occupation) and confounders associated with motor and social development; (b) completing a standardized screening instrument that addresses their child's motor and social development at chronologic or gestation-corrected ages 4, 8, 12, 16, 20, 24, 30, and 36 months; and (c) providing information on the child's growth and medical history (e.g., illnesses, diagnoses of birth defects, major impairments).  Whenever possible, records will be linked to other pertinent health records (e.g., early intervention programs, WIC, birth defect or cancer registries).  Depending upon State requirements, screening results will be communicated to parents, and parents expressing concern about their children will be given contact information for State-approved developmental assessment centers and early intervention programs.

It is anticipated that one (1) award of a cost-reimbursement, incrementally funded completion-type contract, with a period of performance of four years, will result from the Request for Proposal (RFP).  This announcement is not an RFP.  

Request for Proposals

The RFP NIH-NICHD-2007-04 is available electronically through the website FedBizOpps (URL: http://www.fedbizopps.gov or through the NICHD website at http://www.nichd.nih.gov/funding/grantcontract, Research and Development Contracts, Contract Opportunities – Federal Business Opportunities.  The Government does not intend to release hard copies of the RFP; therefore, potential offerors are responsible for downloading their own copy of the solicitation.  The electronic RFP for this solicitation will include all information required for submission of an offeror's proposal.  This notice does not commit the Government to award a contract. 

Inquiries

Fred Ettehadieh
Contracting Officer
NICHD R&D Contracts Management Branch
6100 Executive Boulevard, Room 7A07, MSC 7510
Bethesda, Maryland 20892-7510 
Telephone:  (301) 435-6961
No collect calls will be accepted
FAX:  (301) 402-3676
Email:  fe19w@nih.gov

Elizabeth Osinski
Contracting Officer
NICHD R&D Contracts Management Branch
6100 Executive Boulevard, Room 7A07, MSC 7510
Bethesda, Maryland 20892-7510 
Telephone:  (301) 435-6947
No collect calls will be accepted
FAX:  (301) 402-3676
Email:  eo43w@nih.gov

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