The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.
| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 25, 2012 |
| Last Updated Date | October 31, 2012 |
| Start Date ICMJE | September 2010 |
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
cumulative delivery rate [ Time Frame: 1999-2006 ] [ Designated as safety issue: Yes ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01720134 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate. |
| Official Title ICMJE | Not Provided |
| Brief Summary | Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher than the 1% after natural conception, related to the number of embryos transferred, and preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART cycles are reimbursed for female patients younger than 43 with a Belgian insurance number since July 2003, but only if a limited number of embryos is transferred depending on female age and cycle rank. Although this policy has resulted in a significant reduction in the MPR after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if the cumulative delivery rate per patient is affected by this legislation. The aim of this study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when compared to the situation before 2003. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | patients undergoing IVF/ICSI cycles |
| Condition ICMJE | Impact of Legislation on Cumulative Delivery Rate |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) |
|
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 1258 |
| Completion Date | July 2012 |
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years to 43 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Belgium |
| Administrative Information | |
| NCT Number ICMJE | NCT01720134 |
| Other Study ID Numbers ICMJE | S53562 |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Sophie Debrock, Katholieke Universiteit Leuven |
| Study Sponsor ICMJE | Katholieke Universiteit Leuven |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Katholieke Universiteit Leuven |
| Verification Date | October 2012 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|