Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
This study is ongoing, but not recruiting participants.
Sponsor:
Yale University
Collaborators:
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
Information provided by (Responsible Party):
Heping Zhang, Yale University
ClinicalTrials.gov Identifier:
NCT00902382
First received: May 13, 2009
Last updated: August 25, 2016
Last verified: August 2016
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Purpose
To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
| Condition |
|---|
|
Infertility |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- The relative risks of genetic abnormalities identified at birth and within the first 60 days of life [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
- The relative risk of structural anomalies [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
- The relative risk of cognitive differences [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
- The relative risk of perceived differences of neuro-developmental milestones [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The rate of pregnancy complications, including pregnancy loss [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
- Rates of neonatal and infant medical disorders [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
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: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Infertile women who conceive spontaneously
|
|
2
Infertile women who conceive on various ovulation stimulation medications
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902382
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902382
Locations
| United States, Alabama | |
| University of Alabama Birmingham | |
| Birmingham, Alabama, United States, 35249-7333 | |
| United States, California | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5317 | |
| 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, New Jersey | |
| Hackensack University | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| 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 | |
Sponsors and Collaborators
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
Investigators
| 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 | The University of Texas Health Science Center at San Antonio |
| 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 |
More Information
| Responsible Party: | Heping Zhang, Principal Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT00902382 History of Changes |
| Other Study ID Numbers: | RMN-PregReg RMN Pregnancy Registry |
| Study First Received: | May 13, 2009 |
| Last Updated: | August 25, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Infertility Ovulation stimulation Pregnancy |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on September 26, 2016