Clinical trial NCT04373239: Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia
Official title: Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assisted Reproductive Techniques
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women registered in Perinatal Services BC database with live births between April 2008 and March 2018.

Brief summary: Investigators will examine trends in ART use in BC specifically. The use of ART has drastically changed the management of infertility, with worldwide estimates exceeding 1.8 million ART cycles in 2010 alone. Moreover, an excess of six million children have been conceived using ART. Although various countries have published their live birth rates associated with common ART treatment strategies, British Columbia has yet report on its rates. With varying differences in ART practices, whether clinical or laboratory, it is expected live birth rates due to ART to vary depending on region analyzed. Analyzing the live birth rate in BC would not only allow for a benchmark for assessing future improvement, and trends in infertility diagnosis and management, but also allow for comparison to other provinces and countries. The aim of this part of the study is to describe ART cycle contribution to live birth rate in BC from April 2008 to March 2018, which has not been addressed in the literature as of yet. Not only will it give healthcare providers and patients information about this emerging approach to infertility but also provide a impetus for healthy policy makers to adopt a model for partially or fully publicly funded ART, as seen in Ontario and soon Quebec.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Live birth rate
timeFrame: Date of delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Mohamed Bedaiwy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: