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Sponsors and Collaborators: |
Yale University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Penn State University University of Colorado at Denver and Health Sciences Center University of Michigan University of Pennsylvania University of Texas University of Vermont Wayne State University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00902382 |
To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
Condition |
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Infertility |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications |
Mothers of newborn infants will be asked to consent to the collection of buccal cells from their infants for DNA testing. Fathers will also be asked to provide buccal cells via buccal swab smears, if blood has not been obtained from them in the course of an RMN trial. The DNA specimens will be available for use in other vetted studies to enable study of independent genetic and environmental factors and gene-environment interactions for a broad range of birth defects and infertility.
Estimated Enrollment: | 1650 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | May 2017 |
Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Infertile women who conceive spontaneously
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Infertile women who conceive on various ovulation stimulation medications
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This will be an observational cohort trial of the pregnancy of women who conceive in RMN trials, and of their resulting infants through the first 3 years of life. Study specific procedures will include a patient completed log of prescribed and over the counter medications taken during a normal pregnancy, a review of their pregnancy, delivery, and neonatal records, an exam of the infant within 60 days of birth by a dysmorphologist, and yearly review of infant medical records, growth charts, and a yearly parent administered developmental questionnaire (Ages and Stages) for the first three years of the infant's life.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The population will include women with infertility who receive ovulation stimulation drugs within the context of a Reproductive Medicine Network sponsored trial as well as their infants.
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06511 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, Pennsylvania | |
Pennsylvania State University College of Medicine | |
Hershey, Pennsylvania, United States, 17033 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78207 | |
United States, Vermont | |
University of Vermont | |
Burlington, Vermont, United States, 05405 |
Principal Investigator: | Esther Eisenberg, MD, MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Study Chair: | Nanette Santoro, MD | Albert Einstein College of Medicine of Yeshiva University |
Principal Investigator: | Richard Legro, MD | Pennsylvania State University College of Medicine |
Study Director: | Robert Brzyski, MD, PhD | University of Texas |
Study Director: | Peter Casson, MD | University of Vermont |
Principal Investigator: | Michael Diamond, MD | Wayne State University |
Study Director: | Heping Zhang, PhD | Yale University |
Study Director: | Gregory Christman, MD | University of Michigan |
Study Director: | Christos Coutifaris, MD | University of Pennsylvania |
Study Director: | William Schlaff, MD | University of Colorado Denver Health Science Center |
Responsible Party: | NICHD ( Esther Eisenberg, MD, MPH, Project Scientist ) |
Study ID Numbers: | RMN-PregReg, RMN Pregnancy Registry |
Study First Received: | May 13, 2009 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00902382 History of Changes |
Health Authority: | United States: Institutional Review Board |
Infertility Ovulation stimulation Pregnancy |
Genital Diseases, Female Infertility Genital Diseases, Male |
Genital Diseases, Female Infertility Genital Diseases, Male |