NIH GUIDE, Volume 22, Number 31, August 27, 1993


P.T. 34


  Human Reproduction/Fertility 



National Institute of Child Health and Human Development

The Contraceptive and Reproductive Evaluation Branch, National

Institute of Child Health and Human Development (NICHD), seeks

sources for a study of the long-term sequelae of exposure to

fertility drugs.  The primary objective is to determine whether and,

if so, to what degree, exposure to ovulation-inducing drugs increases

the risk of ovarian cancer.  The secondary objective is to shed light

on other potentially serious adverse effects of ovulation induction.

The proposed cohort study would involve subjects from one or more

well-defined historic cohorts with data already collected on

reproductive, personal, familial, and any other relevant risk

factors, including complete fertility drug history (dosage and

duration of usage), as well as histological diagnoses of any

malignancies occurring among the participants.  Enough women must

have been already enrolled to ensure sufficient statistical power to

test hypotheses in subsets of the data, such as anovulatory versus

other forms of infertility and women of different parity and

gravidity.  Due to the relative rarity of ovarian cancer, all

interested parties must be able to document the existence of an

historic cohort currently providing at least 30,000 woman-years of

follow-up after exposure.  This requirement is based on available

incidence data to detect a three-fold difference in risk of ovarian

cancer.  Offerors should have expertise in the field of reproductive

epidemiology, particularly with regard to ovulation induction and

ovarian cancer.  Offerors should also have experience in assembling

and obtaining adequate follow-up of large cohorts and in collecting,

managing, and analyzing large epidemiologic data bases.  The

Government estimates the effort to be approximately 4.5 technical

staff-years.  It is anticipated that one cost-reimbursement

incrementally funded type contract will be awarded for a period of 54



This announcement is not a request for proposals (RFP).  RFP No.

NICHD-CRE-93-12 is now available.  Copies of the RFP may be obtained

by sending a written request, with a self-addressed label, or a FAX

request to:

Charles W. Grewe, Contracting Officer

Office of Grants and Contracts

National Institute of Child Health and Human Development

6100 Building, Room 7A07

Bethesda, MD  20892

FAX:  (301) 402-3676


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