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

Impact of Legislation on Cumulative Delivery Rate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720134
• Other study ID #: S53562
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: March 29, 2017
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2017
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1258
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Impact of Legislation on Cumulative Delivery Rate

Locations

Country	Name	City	State
Belgium	Leuven University Fertility Center	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative delivery rate		1999-2006