The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sophie Debrock, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01720134
First received: October 25, 2012
Last updated: October 31, 2012
Last verified: October 2012

October 25, 2012
October 31, 2012
September 2010
June 2012   (final data collection date for primary outcome measure)
cumulative delivery rate [ Time Frame: 1999-2006 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01720134 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

patients undergoing IVF/ICSI cycles

Impact of Legislation on Cumulative Delivery Rate
Not Provided
  • after legislation 1st july 2003
    2003-2006
  • before legislation 1st july 2003
    1999-2003
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1258
July 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with their first IVF/ICSI cycle

Exclusion Criteria:

  • cycles without oocytes or sperm, oocyte reception cycles, embryo reception cycles, cycles with preimplantation genetic diagnosis/screening
Both
18 Years to 43 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01720134
S53562
Not Provided
Sophie Debrock, Katholieke Universiteit Leuven
Katholieke Universiteit Leuven
Not Provided
Not Provided
Katholieke Universiteit Leuven
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP