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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373239
Other study ID # H20-00461-B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2008
Est. completion date March 2018

Study information

Verified date April 2020
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

We 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, one would expect 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.


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 Marcch 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. All 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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Assisted Reproductive Technology
Assisted reproductive technology includes IVF and IVF+ICSI.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Outcome

Type Measure Description Time frame Safety issue
Primary Live birth rate Live birth rate Date of delivery
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