LONGITUDINAL STUDY OF ESTROGEN AND PROGESTERONE EFFECTS ON BIOMARKERS OF 
OXIDATIVE STRESS AND ANTIOXIDANT STATUS DURING THE MENSTRUAL CYCLE

RELEASE DATE:  February 12, 2004

NOTICE: NOT-HD-04-006

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

RFP AVAILABLE: RFP-NIH-NICHD-2004-01

The Division of Epidemiology, Statistics and Prevention Research, National 
Institute of Child Health and Human Development (DESPR/NICHD) is planning to 
award a contract for a program entitled, "Longitudinal Study of the Estrogen 
and Progesterone Effects on Biomarkers of Oxidative Stress and Antioxidant 
Status during the Menstrual Cycle."  The NICHD seeks a contractor capable of 
establishing a longitudinal cohort study to determine the pre-menopausal 
cyclic relationship between oxidative stress biomarkers and hormonal 
fluctuations in order to analyze their effect on women's reproductive health 
and disease.  Recent animal and human studies suggest that oxidative stress 
might be implicated in the risk of female infertility through associations 
with follicular growth, the development of endometriosis, and regulation of 
angiogenesis in the endometrium, but the mechanisms are not completely 
understood.  Although it is known that micronutrient antioxidants, hormones, 
and enzymatic antioxidants are able to neutralize oxygen free radicals and 
inhibit oxidation, the use of these therapies to reduce the risk of 
infertility has been limited by a lack of basic understanding. 

The objectives of this project are:  (1) to study the intra-cycle variation 
of oxidative stress during menstruation; (2) to determine the relationship 
between sex hormones and oxidative stress during the menstrual cycle in pre-
menopausal women; (3) to examine the influence of external factors such as 
over-the-counter medications, cigarette smoking, alcohol consumption, and 
exercise on oxidative stress and hormone levels; and (4) to evaluate the 
validity and reliability of biomarkers of oxidative stress and antioxidant 
status in blood and urine.  To meet these objectives, a prospective 
longitudinal cohort study is being designed.  An estimated total of 
approximately 260 pre-menopausal, healthy (chlamydia-free) women will be 
required to participate in this study.  

To receive consideration for a contract award, an offeror must be able to:  
(1) Demonstrate a clear understanding of menstrual function and its relation 
to oxidative stress, including the potential role of environmental factors, 
biological variability, and laboratory measurements; (2) provide evidence of 
a solid understanding regarding the utility and feasibility of a longitudinal 
design for empirically assessing the relation between biomarkers of oxidative 
stress, lifestyle factors, and human reproduction and development; and (3)  
provide evidence of an ability to a) identify, recruit, and retain 
participants; b) collect longitudinal data and biologic specimens using 
quality assurance procedures (include information on what quality assurance 
procedures have been/will be used); and c) establish and comply with a study 
protocol in collaboration with the NICHD.  

The required service is defined as code 541990 under the North American 
Industry Classification System (NAICS).  The Request for Proposal (RFP) is 
available through the web site at http://FedBizOpps.gov.  All responses must 
be submitted on or before March 23, 2004, to Robert Stallings, Contract 
Specialist, NICHD, at the address listed below. Questions may be directed to 
Robert Stallings, Contract Specialist (see contact information, below).  

Fully electronic copies will not be accepted, but portions of the proposal 
may be provided on disc.  The reference number to be used for this 
announcement is: RFP NICHD-2004-01.  All correspondence must cite the 
reference number as provided. The resultant contract is anticipated to have 
duration of two years.

INQUIRIES 

For further information, contact: 

Robert Stallings  
Contract Specialist
Contracts Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 7A07, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service) 
Telephone: (301) 496-6965 
FAX: (301) 402-3676    
Email:  bs79d@nih.gov

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