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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01720134
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Impact of Legislation on Cumulative Delivery Rate

Study Design

Study Type : Observational
Actual Enrollment : 1258 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : September 2010
Primary Completion Date : June 2012
Study Completion Date : July 2012
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. cumulative delivery rate [ Time Frame: 1999-2006 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720134


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

Responsible Party: Sophie Debrock, Prof. Dr, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01720134     History of Changes
Other Study ID Numbers: S53562
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017