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Lifestyle and Fertility Study on Antioxidant Status, Diet and Early Pregnancy

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ClinicalTrials.gov Identifier: NCT00642590
Recruitment Status : Unknown
Verified March 2016 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2008
Last Update Posted : March 31, 2016
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Penn State University
Tufts University
Emory University
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

March 21, 2008
March 25, 2008
March 31, 2016
March 2008
December 2016   (Final data collection date for primary outcome measure)
  • Time to pregnancy [ Time Frame: Couples will be followed from preconception to the outcome of pregnancy. ]
    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 ]
    Pregnancy and subsequent early loss will be determined by measuring urinary human chorionic gonadotropin (hCG).
Not Provided
Complete list of historical versions of study NCT00642590 on ClinicalTrials.gov Archive Site
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Lifestyle and Fertility Study on Antioxidant Status, Diet and Early Pregnancy
Antioxidant Status, Diet and Early Pregnancy
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood, plasma, serum, urine
Non-Probability Sample
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.
  • Infertility
  • Pregnancy
  • Fertility
  • Nutrition
  • Life Style
Not Provided
1
Healthy couples who are planning their first pregnancy.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
266
1150
November 2017
December 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 39 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00642590
R01HD049762( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Dartmouth-Hitchcock Medical Center
  • Penn State University
  • Tufts University
  • Emory University
Principal Investigator: Marlene B. Goldman, MS, ScD Dartmouth-Hitchcock Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2016