InfertilityNCT00902382
Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
An observational study of Infertility, run by Yale University at 13 sites in United States.
Trial summary
To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- How many people
- 264 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2009to 27 Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Positive serum hCG within the context of a RMN trial;
- History of infertility meeting female subject entry criteria for a RMN trial;
- Informed consent.
Who cannot join
- Unable to comply with the demands of the trial.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
University of Alabama Birmingham
Birmingham, Alabama, 35249-7333
University of Vermont
Burlington, Vermont, 05405
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Wayne State University
Detroit, Michigan, 48201
Hackensack University
Hackensack, New Jersey, 07601
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, 17033
Yale University
New Haven, Connecticut, 06511
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
Stanford University Medical Center
Stanford, California, 94305-5317
About this study
To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
Read the 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.
- Conditions
- Infertility
- Keywords
- Infertility, Ovulation stimulation, Pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Infertile women who conceive spontaneously | |
| 2 | Infertile women who conceive on various ovulation stimulation medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative risks of genetic abnormalities identified at birth and within the first 60 days of life
Measured: 2009 - 2016
The relative risk of structural anomalies
Measured: 2009 - 2016
The relative risk of cognitive differences
Measured: 2009 - 2016
The relative risk of perceived differences of neuro-developmental milestones
Measured: 2009 - 2016
Secondary outcomes (3)
The rate of pregnancy complications, including pregnancy loss
Measured: 2009 - 2016
Rates of neonatal and infant medical disorders
Measured: 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.
Measured: 2009 - 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completion27 Jun 2014
- Study completion27 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Heping Zhang, Yale University
- Investigators
- Esther Eisenberg, MD, MPH, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Nanette Santoro, MD, Study chair, Albert Einstein College of MedicineRichard Legro, MD, Principal investigator, Pennsylvania State University College of MedicineRobert Brzyski, MD, PhD, Study director, The University of Texas Health Science Center at San AntonioPeter Casson, MD, Study director, University of VermontMichael Diamond, MD, Principal investigator, Wayne State UniversityHeping Zhang, PhD, Study director, Yale UniversityGregory Christman, MD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902382
- Sponsor's protocol ID
- RMN-PregReg
- Other IDs
- RMN Pregnancy Registry
- Status last verified
- Feb 2018
- First submitted
- 13 May 2009
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
- ClinicalTrials.gov ID
- NCT00902382
- Acronym / sponsor ID
- RMN-PregReg
- Conditions
- Infertility
- Keywords
- Infertility, Ovulation stimulation, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or 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
- Study start
- May 2009
- Primary completion
- 27 Jun 2014 (actual)
- Study completion
- 27 Jun 2014 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Infertile women who conceive spontaneously |
| 2 | – | –Infertile women who conceive on various ovulation stimulation medications |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Positive serum hCG within the context of a RMN trial;
- History of infertility meeting female subject entry criteria for a RMN trial;
- Informed consent.
Key exclusion criteria (1 listed)
- Unable to comply with the demands of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Eisenberg, MD, MPH principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD study chair
Albert Einstein College of Medicine
Richard Legro, MD principal investigator
Pennsylvania State University College of Medicine
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Yale University at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative risks of genetic abnormalities identified at birth and within the first 60 days of life (time frame: 2009 - 2016). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.