- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04373239
Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Perinatal Services BC maintains a current database on live births, antepartum, intrapartum and postpartum outcomes; including details of ART if used to conceive. Live birth rate, for the purposes of this study, will be defined as the birth of at least one live born baby, with the birth of twins or higher order multiples considered as one live birth. The birth rate for ART will be taken as a proportion for birth rate from ART over total birth rate for given calendar year and the overall period of analysis. Data from April 1 2008 to March 31 2018 on autologous ART treatment cycles and outcomes will be extracted from this database, with approval. Overall proportion of ART contributing to live birth rate will be analyzed as well as sub categorical analysis based on age (younger than 30, 30-34 years, 35-39 years, 40-44 years, and 45 years and older). Only nulliparous women will be included in this study.
Moreover, data will be analyzed by calendar year in which baby from ART delivered to evaluate overall trends in ART outcomes. The total live birth rate for all of BC will serve as the denominator.
Although the data will be reviewed and rules interpreted by the principal investigator of this study, a biostatistician will be hired to carry out the necessary statistical analysis.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Nulliparous women registered in Perinatal Services BC database with live birth between April 2008 and March 2018
Exclusion Criteria:
- multiparous women
- women with missing data in Perinatal Services BC database including gravid, parity, age, date of birth
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Women in BC conceiving by ART
All women in BC registered in the Perinatal Services BC database having undergone Assisted Reproductive Technology.
Assisted Reproductive Technology will consist of in vitro fertilization (+/-ICSI).
Data from April 1, 2008 to March 31 2018 will be analyzed for live birth rate.
|
Assisted reproductive technology includes IVF and IVF+ICSI.
|
|
Women in BC conceiving spontaneously
he comparison group will be all women in BC registered in the Perinatal Services BC database with spontaneously conceived pregnancies between April 1, 2008 to March 31 2018.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Live birth rate
Time Frame: Date of delivery
|
Live birth rate
|
Date of delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed Bedaiwy, MD, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H20-00461-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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