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Novel approaches in in-vitro fertilisation (IVF)
ISRCTN ISRCTN35766970
DOI 10.1186/ISRCTN35766970
ClinicalTrials.gov identifier
EudraCT number
Public title Novel approaches in in-vitro fertilisation (IVF)
Scientific title
Acronym N/A
Serial number at source NTR587
Study hypothesis Strategies involving shorter and milder ovarian stimulation protocols and single embryo transfer may allow for more in-vitro fertilisation (IVF) cycles in the same period of time, resulting in similar term live birth rate per treatment period despite a minor reduction in birth rate per treatment cycle.
Lay summary
Ethics approval Received from the local medical ethics committee
Study design Multicentre, randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Infertility
Participants - inclusion criteria 1. Patients with an indication for IVF or IVF/intracytoplasmic sperm injection (ICSI) based on tubal, male or unexplained infertility were recruited
2. Patients less than 38 years with a normal menstrual cycle (cycle length between period 25 - 35 days) and without severe obesity or underweight (body mass index [BMI] 18 - 28 kg/m^2) were eligible for the study
Participants - exclusion criteria Does not comply with the above inclusion criteria.
Anticipated start date 01/02/2002
Anticipated end date 01/03/2005
Status of trial Completed
Patient information material
Target number of participants 400
Interventions Patients were randomly assigned to undergo either:
1. Mild treatment (mild ovarian stimulation with gonadotropin-releasing hormone [GnRH] antagonist co-treatment combined with single embryo transfer), or
2. Standard treatment (stimulation with a GnRH agonist long-protocol and transfer of two embryos)
Primary outcome measure(s) The primary outcome parameters chosen for this study were:
1. Pregnancy within one year of treatment after randomisation leading to term (greater than 37 weeks gestation) live birth
2. Total costs per couple and child up to six weeks after expected delivery
3. Patient discomfort/distress during IVF treatment
Secondary outcome measure(s) No secondary outcome measures
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/17336650
2. http://www.ncbi.nlm.nih.gov/pubmed/17586832
Contact name Dr  Esther  Heijnen
  Address Department of Reproductive Medicine
University Medical Center Utrecht
Heidelberglaan 100
  City/town Utrecht
  Zip/Postcode 3584 CX
  Country Netherlands
  Email esther.heijnen@organon.com
Sponsor University Medical Centre Utrecht (UMCU) (The Netherlands)
  Address Department of Reproductive Medicine
Heidelberglaan 100
  City/town Utrecht
  Zip/Postcode 3584 CX
  Country Netherlands
  Sponsor website: http://www.umcutrecht.nl/zorg/
Date applied 08/03/2006
Last edited 15/10/2008
Date ISRCTN assigned 08/03/2006
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