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

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.

Study Overview

• Status: Completed
• Conditions: Impact of Legislation on Cumulative Delivery Rate

• Study Type: Observational
• Enrollment (Actual): 1258

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Leuven University Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing IVF/ICSI cycles

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
after legislation 1st july 2003; 2003-2006
before legislation 1st july 2003; 1999-2003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cumulative delivery rate	1999-2006

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: S53562