Clinical trial NCT00902382: Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
Official title: Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Ovulation stimulation
Pregnancy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Penn State University
name: University of Colorado, Denver
name: University of Michigan
name: University of Pennsylvania
name: University of Texas
name: University of Vermont
name: Wayne State University
First posted: 2009-05-15
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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 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.

Primary outcomes:
measure: The relative risks of genetic abnormalities identified at birth and within the first 60 days of life
timeFrame: 2009 - 2016
measure: The relative risk of structural anomalies
timeFrame: 2009 - 2016
measure: The relative risk of cognitive differences
timeFrame: 2009 - 2016
measure: The relative risk of perceived differences of neuro-developmental milestones
timeFrame: 2009 - 2016
Secondary outcomes:
measure: The rate of pregnancy complications, including pregnancy loss
timeFrame: 2009 - 2016
measure: Rates of neonatal and infant medical disorders
timeFrame: 2009 - 2016
measure: 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.
timeFrame: 2009 - 2016
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Hershey
country: United States
facility: Pennsylvania State University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Esther Eisenberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Nanette Santoro, MD
role: STUDY_CHAIR
affiliation: Pennsylvania State University College of Medicine
name: Richard Legro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Robert Brzyski, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Vermont
name: Peter Casson, MD
role: STUDY_DIRECTOR
affiliation: Wayne State University
name: Michael Diamond, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Heping Zhang, PhD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Gregory Christman, MD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Christos Coutifaris, MD
role: STUDY_DIRECTOR
affiliation: University of Colorado Denver Health Science Center
name: William Schlaff, MD
role: STUDY_DIRECTOR
References: