Assisted Reproductive TechniquesNCT04373239
Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia
An observational study of Assisted Reproductive Techniques, run by University of British Columbia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Assisted Reproductive Techniques
- What is being tested?
- Assisted Reproductive Technology
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Mar 2018
- How long will I take part?
- 9 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All women registered in Perinatal Services BC database with live births between April 2008 and March 2018.
Who may be able to join
- Nulliparous women registered in Perinatal Services BC database with live birth between April 2008 and March 2018
Who cannot join
- multiparous women
- women with missing data in Perinatal Services BC database including gravid, parity, age, date of birth
About this study
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.
Read the 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.
- Conditions
- Assisted Reproductive Techniques
- Being tested
- Assisted Reproductive Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted Reproductive TechnologyProcedure or surgery
Assisted reproductive technology includes IVF and IVF+ICSI.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Assisted Reproductive Technology | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth rate
Measured: Date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study startApr 2008
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechniquesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Other
- Enrolment
- 1,000 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Bedaiwy, University of British Columbia
- Investigators
- Mohamed Bedaiwy, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373239
- Sponsor's protocol ID
- H20-00461-B
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends in Live Birth Rates Attributable to Assisted Reproductive Technology in British Columbia
- ClinicalTrials.gov ID
- NCT04373239
- Acronym / sponsor ID
- H20-00461-B
- Conditions
- Assisted Reproductive Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 May 2020 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 9 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women in BC conceiving by ART | – | Procedure: Assisted Reproductive TechnologyAll 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women registered in Perinatal Services BC database with live births between April 2008 and March 2018.
Key inclusion criteria (1 listed)
- Nulliparous women registered in Perinatal Services BC database with live birth between April 2008 and March 2018
Key exclusion criteria (2 listed)
- multiparous women
- women with missing data in Perinatal Services BC database including gravid, parity, age, date of birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted Reproductive TechnologyAssisted reproductive technology includes IVF and IVF+ICSI. | Procedure or surgery | Women in BC conceiving by ART |
Primary outcome
Live birth rate
Time frame: Date of delivery
Live birth rate
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 13 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Mohamed Bedaiwy, MD, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Assisted Reproductive Techniques, run by University of British Columbia.
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 1 inclusion and 2 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Live birth rate (time frame: Date of delivery). 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 13 Dec 2024.