Trial record 3 of 463 for:    nichd Women's Health

Lifestyle and Fertility Study (ISIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Penn State University
Tufts University
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00642590
First received: March 21, 2008
Last updated: November 15, 2013
Last verified: May 2013
  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
Infertility
Pregnancy Early
Preconception Care
Women's Health
Lifestyle Factors

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

Resource links provided by NLM:


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 ]
    Time to pregnancy is defined as the number of menstrual cycles from the cessation of contraception to a clinically recognized pregnancy.

  • Early pregnancy loss [ Time Frame: First trimester of pregnancy ] [ Designated as safety issue: No ]
    Pregnancy and subsequent early loss will be determined by measuring urinary human chorionic gonadotropin (hCG).


Biospecimen Retention:   Samples With DNA

Whole blood, plasma, serum, urine


Enrollment: 140
Study Start Date: March 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healthy couples who are planning their first pregnancy.

Detailed Description:

Only one-fourth to one-third of fertilized human eggs are likely to survive to produce a term baby. The causes of these reproductive failures are substantially unknown, but scientific evidence suggests that they may, in part, be due to exposures such as pre-conception nutrition, that may result in insults to the oocyte and periconceptual embryo. Early reproductive events may have long-lasting impact as several have recently been identified as antecedents to adult-onset diseases. The goal of this prospective epidemiologic study is to evaluate the hypothesis that increased oxidative stress results in delayed time-to-pregnancy or early pregnancy loss. Recently, reactive oxygen species (ROS) have been associated with spontaneous abortion, preeclampsia, and premature preterm rupture of the membranes in women and defective sperm function in men. In living cells ROS are formed continuously as a consequence of both biochemical reactions and external factors. In this prospective cohort study of healthy couples who are planning pregnancy, we are evaluating time-to-pregnancy, defined as the number of menstrual cycles from the cessation of contraception to a clinically recognized pregnancy, and early unrecognized pregnancy loss. Unrecognized pregnancy and subsequent early loss will be determined by measuring urinary human chorionic gonadotropin (hCG). Diet will be assessed in both partners prior to conception using the Block food frequency questionnaire and serum assays for the antioxidants vitamins C and E, the carotenoids, and selenium. Two urinary biomarkers of oxidative stress, 8-hydroxy-2'-deoxyguanosine and F2a-isoprostanes, and a serum biomarker of antioxidative capacity, oxygen radical absorbance capacity, will be measured in the women. The proposed study has a number of strengths: 1) it is large and prospective in design, with diet and oxidative stress measured prior to conception; 2) a highly sensitive and specific assay for hCG will be used to detect conceptions as early as the time of implantation; 3) dietary intake and biomarker assays of antioxidant status will be assessed twice during the preconception period using state-of-the-art assessment methods including a diet calibration substudy; 4) the proposed research has the potential to fill gaps in our understanding of the role of diet in achieving successful conception, an area where very little investigation has been done.

  Eligibility

Ages Eligible for Study:   18 Years to 39 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 18 to 39, and both partners must be in good general health with no history of infertility.

Criteria

Inclusion Criteria:

  • Female is between 18 and 39 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Penn State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
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:
Publications:
Patchell FS, Ruder EH, Mitchell DC, Hartman TJ, Goldman MB. A comparison of energy and antioxidant intake using the Block FFQ and unannounced 24-hour recalls among couples planning pregnancy. 7th International Conference on Diet and Activity Methods, June 4-7, 2009, Washington, DC.

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00642590     History of Changes
Other Study ID Numbers: R01 HD049762
Study First Received: March 21, 2008
Last Updated: November 15, 2013
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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 26, 2014