Infertility Clinical Trial
Official title:
Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
Verified date | February 2018 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
Status | Completed |
Enrollment | 264 |
Est. completion date | June 27, 2014 |
Est. primary completion date | June 27, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Positive serum hCG within the context of a RMN trial; - History of infertility meeting female subject entry criteria for a RMN trial; - Informed consent. Exclusion Criteria: - Unable to comply with the demands of the trial. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Colorado | Aurora | Colorado |
United States | University of Alabama Birmingham | Birmingham | Alabama |
United States | University of Vermont | Burlington | Vermont |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Wayne State University | Detroit | Michigan |
United States | Hackensack University | Hackensack | New Jersey |
United States | Pennsylvania State University College of Medicine | Hershey | Pennsylvania |
United States | Yale University | New Haven | Connecticut |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Stanford University Medical Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Yale University | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The relative risks of genetic abnormalities identified at birth and within the first 60 days of life | 2009 - 2016 | ||
Primary | The relative risk of structural anomalies | 2009 - 2016 | ||
Primary | The relative risk of cognitive differences | 2009 - 2016 | ||
Primary | The relative risk of perceived differences of neuro-developmental milestones | 2009 - 2016 | ||
Secondary | The rate of pregnancy complications, including pregnancy loss | 2009 - 2016 | ||
Secondary | Rates of neonatal and infant medical disorders | 2009 - 2016 | ||
Secondary | 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. | 2009 - 2016 |
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