Significance of routine hysteroscopy prior to a first IVF treatment cycle
The aim of the proposed study is to assess whether diagnosing and treating unsuspected intrauterine abnormalities by SIS and/or routine office hysteroscopy prior to a first IVF/ICSI treatment cycle improves the IVF outcome and with that the cost effectiveness of the fertility treatment
Patients scheduled for a first IVF/ICSI treatment at the one of the participating hospitals will undergo randomization for the routine fertility work-up versus the routine work-up added up with diagnostic tests to evaluate the uterine cavity ((SIS and) hysteroscopy). In case of randomization for the latter, a (SIS and a) standard office hysteroscopy will be performed in the early-mid follicular phase of a cycle (Day 3-9) 1–3 months before starting the IVF/ICSI Treatment on the spot of detected intrauterine abnormalities will be carried out during the hysteroscopy. In both intervention arms IVF/ICSI treatment is initiated and outcome during an eighteen months treatment period recorded. Also, the patient’s tolerance and preferences will be investigated. Finally, a cost-analysis based on the study results will be performed.
All patients, indicated for a first IVF/ICSI treatment cycle at one of the participating hospitals.
Cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles).
Secondary study parameters/endpoints
Cumulative implantation rate and miscarry rate achieved within 18 months of IVF/ICSI treatment after randomisation (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
Cumulative miscarry rate within 18 months of IVF/ICSI treatment after randomization (obtained in both treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles)
Cost calculations of, SIS, hysteroscopy procedures and the IVF treatment
Patient tolerance of a SIS and diagnostic/therapeutic hysteroscopy procedure
01-04-2011 to 01-01-2015
Dr. F.J.M. Broekmans, UMCUtrecht, divisie Vrouw en Baby.
ProtocolINSIGHT protocol 27-01-10 (pdf)
Dr. Helen Torrance
UMC Utrecht, Afd Voortplantingsgeneeskunde
3508 GA Utrecht, Nederland
Tel. 088 7555 555 sein4296