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| ID | Type | Description | Link |
|---|---|---|---|
| RMN Pregnancy Registry |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Penn State University | OTHER |
| University of Colorado, Denver | OTHER |
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To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Infertile women who conceive spontaneously | ||
| 2 | Infertile women who conceive on various ovulation stimulation medications |
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| Measure | Description | Time Frame |
|---|---|---|
| The relative risks of genetic abnormalities identified at birth and within the first 60 days of life | 2009 - 2016 | |
| The relative risk of structural anomalies | 2009 - 2016 | |
| The relative risk of cognitive differences | 2009 - 2016 | |
| The relative risk of perceived differences of neuro-developmental milestones | 2009 - 2016 |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of pregnancy complications, including pregnancy loss | 2009 - 2016 | |
| Rates of neonatal and infant medical disorders | 2009 - 2016 | |
| Rates of infant growth related to use of letrozole for stimulation of ovulation compared to other treatment modalities for ovulation stimulation, including compared to women who conceive spontaneously. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Esther Eisenberg, MD, MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator |
| Nanette Santoro, MD | Albert Einstein College of Medicine | Study Chair |
| Richard Legro, MD | Pennsylvania State University College of Medicine | Principal Investigator |
| Robert Brzyski, MD, PhD | The University of Texas Health Science Center at San Antonio | Study Director |
| Peter Casson, MD | University of Vermont | Study Director |
| Michael Diamond, MD | Wayne State University | Principal Investigator |
| Heping Zhang, PhD | Yale University | Study Director |
| Gregory Christman, MD | University of Michigan | Study Director |
| Christos Coutifaris, MD | University of Pennsylvania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35249-7333 | United States | ||
| Stanford University Medical Center |
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| University of Michigan |
| OTHER |
| University of Pennsylvania | OTHER |
| University of Texas | OTHER |
| University of Vermont | OTHER |
| Wayne State University | OTHER |
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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.
| 2009 - 2016 |
| William Schlaff, MD | University of Colorado Denver Health Science Center | Study Director |
| Stanford |
| California |
| 94305-5317 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Hackensack University | Hackensack | New Jersey | 07601 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Pennsylvania State University College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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