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OpenTrials
Completed

NCT Number: NCT01720134

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.

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Key information

Age range

18 year–43 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Leuven University Fertility Center

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. cumulative delivery rate

    Time frame: 1999-2006

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2012
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.