Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
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ClinicalTrials.gov Identifier: NCT00902382 |
Recruitment Status
:
Completed
First Posted
: May 15, 2009
Last Update Posted
: February 7, 2018
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Condition or disease |
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Infertility |
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.
Study Type : | Observational |
Actual Enrollment : | 264 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | June 27, 2014 |
Actual Study Completion Date : | June 27, 2014 |

Group/Cohort |
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1
Infertile women who conceive spontaneously
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2
Infertile women who conceive on various ovulation stimulation medications
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- The relative risks of genetic abnormalities identified at birth and within the first 60 days of life [ Time Frame: 2009 - 2016 ]
- The relative risk of structural anomalies [ Time Frame: 2009 - 2016 ]
- The relative risk of cognitive differences [ Time Frame: 2009 - 2016 ]
- The relative risk of perceived differences of neuro-developmental milestones [ Time Frame: 2009 - 2016 ]
- The rate of pregnancy complications, including pregnancy loss [ Time Frame: 2009 - 2016 ]
- Rates of neonatal and infant medical disorders [ Time Frame: 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. [ Time Frame: 2009 - 2016 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902382
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 |
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, Inc. | |
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 |
Responsible Party: | Heping Zhang, Principal Investigator, Yale University |
ClinicalTrials.gov Identifier: | NCT00902382 History of Changes |
Other Study ID Numbers: |
RMN-PregReg RMN Pregnancy Registry |
First Posted: | May 15, 2009 Key Record Dates |
Last Update Posted: | February 7, 2018 |
Last Verified: | February 2018 |
Keywords provided by Heping Zhang, Yale University:
Infertility Ovulation stimulation Pregnancy |
Additional relevant MeSH terms:
Infertility Genital Diseases, Male Genital Diseases, Female |