The ISIS Lifestyle and Fertility Study

This study is currently recruiting participants.

Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), April 2009

First Received: March 21, 2008 Last Updated: April 14, 2009 History of Changes

Sponsors and Collaborators:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Dartmouth-Hitchcock Medical Center Penn State University Tufts University Harvard Vanguard Medical Associates
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00642590

Purpose

Researchers believe that certain lifestyle factors can influence a couple's ability to conceive and have a baby. The ISIS Study will look at the health habits of couples who are planning their first pregnancy, and then attempt to measure the effect these habits have on the couple's fertility. The ISIS Study hopes to clarify the link between lifestyle and fertility, and believes that information gained in this project may help future couples in their attempts to conceive.

Condition
Fertility Infertility Pregnancy Preconception Care Women's Health

MedlinePlus related topics: Diets Infertility Women's Health

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Antioxidant Status, Diet and Early Pregnancy

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Time to pregnancy [ Time Frame: Couples will be followed from preconception to the outcome of pregnancy. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood, plasma, serum, urine

Estimated Enrollment:	1150
Study Start Date:	March 2008

Groups/Cohorts
1 Healthy couples who are planning their first pregnancy.

Eligibility

Ages Eligible for Study:	20 Years to 34 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

We are looking for couples who are planning a pregnancy. This must be a first pregnancy for women, ages 20-34, and both partners must be in good general health with no history of infertility.

Criteria

Inclusion Criteria:

Female is between 20-34 years of age
Female is having regular periods
Couple is currently using some form of contraception (e.g., oral contraceptives, barrier methods, timing method), but planning to get pregnant in the near future.

Exclusion Criteria:

Female has a previous pregnancy
Female has tried for 12 months or more to achieve a pregnancy without success, or has undergone fertility treatment
Female has received a diagnosis of polycystic ovary syndrome (PCOS)
Female has another serious medical condition (e.g. heart disease, kidney disease, diabetes, thyroid disease, clinical depression, or an acute chronic infection)
Male has tried for 12 months or more to achieve a conception without success
Male has had a fertility related condition (e.g., zoo- or oligospermia, other abnormal semen analysis, cryptorchidism, or testicular cancer)
Male has another serious medical condition (e.g. heart disease, kidney disease, diabetes, thyroid disease, clinical depression, or an acute chronic infection)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642590

Contacts

Contact: Study Coordinator

781-434-6556

isisfertility@dartmouth.edu

Locations

United States, Massachusetts
Dartmouth Medical School/Boston IVF	Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Study Coordinator 781-434-6556 isisfertility@dartmouth.edu
Principal Investigator: Marlene B. Goldman, ScD
United States, Pennsylvania
Penn State University	Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Terryl J. Hartman, PhD, MPH 814-865-8747 tjh9@psu.edu
Principal Investigator: Terryl J. Hartman, PhD

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Dartmouth-Hitchcock Medical Center

Penn State University

Tufts University

Harvard Vanguard Medical Associates

Investigators

Principal Investigator:

Marlene B. Goldman, MS, ScD

Dartmouth-Hitchcock Medical Center

More Information

Additional Information:

ISIS Study website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dartmouth College ( Marlene B. Goldman, ScD )
Study ID Numbers:	R01 HD049762
Study First Received:	March 21, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00642590 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Fertility
Pregnancy
Conception
Infertility

Behavioral
Lifestyle
Preconception care
Women's Health

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Antioxidants
Genital Diseases, Male

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 07, 2009