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
  Purpose

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.


Condition
Impact of Legislation on Cumulative Delivery Rate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • cumulative delivery rate [ Time Frame: 1999-2006 ] [ Designated as safety issue: Yes ]

Enrollment: 1258
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
after legislation 1st july 2003
2003-2006
before legislation 1st july 2003
1999-2003

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing IVF/ICSI cycles

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720134

Locations
Belgium
Leuven University Fertility Center
Leuven, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: Sophie Debrock, Prof. Dr, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01720134     History of Changes
Other Study ID Numbers: S53562
Study First Received: October 25, 2012
Last Updated: October 31, 2012
Health Authority: Belgium:

ClinicalTrials.gov processed this record on April 23, 2014