Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia

Sponsor

University of British Columbia (Other)

Overall Status

Completed

CT.gov ID

NCT04373239

Collaborator

(none)

1,000

Enrollment

119

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Live Birth Rate	Procedure: Assisted Reproductive Technology

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 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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia

Actual Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	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.	Procedure: Assisted Reproductive Technology 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.

Arm

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.

Procedure: Assisted Reproductive Technology

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.

Outcome Measures

Primary Outcome Measures

Live birth rate [Date of delivery]
Live birth rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator: Mohamed Bedaiwy, MD, PhD, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Bedaiwy, Principle Investigator, University of British Columbia

ClinicalTrials.gov Identifier:

NCT04373239

Other Study ID Numbers:

H20-00461-B

First Posted:

May 4, 2020

Last Update Posted:

May 4, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 4, 2020