Status:
UNKNOWN
Lifestyle and Fertility Study on Antioxidant Status, Diet and Early Pregnancy
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
Dartmouth-Hitchcock Medical Center
Penn State University
Conditions:
Infertility
Pregnancy
Eligibility:
All Genders
18-39 years
Brief Summary
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 p...
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 suggest...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT00642590
Start Date
March 1 2008
End Date
November 1 2017
Last Update
March 31 2016
Active Locations (2)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
2
Penn State University
University Park, Pennsylvania, United States, 16802