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OpenTrials
Completed

NCT Number: NCT00902382

Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Alabama Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The relative risks of genetic abnormalities identified at birth and within the first 60 days of life

    Time frame: 2009 - 2016

  2. The relative risk of structural anomalies

    Time frame: 2009 - 2016

  3. The relative risk of cognitive differences

    Time frame: 2009 - 2016

  4. The relative risk of perceived differences of neuro-developmental milestones

    Time frame: 2009 - 2016

Secondary outcomes

  1. The rate of pregnancy complications, including pregnancy loss

    Time frame: 2009 - 2016

  2. Rates of neonatal and infant medical disorders

    Time frame: 2009 - 2016

  3. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

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

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 15, 2009
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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