Dutch Consortium for Healthcare Evaluation in Obstetrics and Gynaecology NVOG Consortium
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inSIGHT

Significance of routine hysteroscopy prior to a first IVF treatment cycle

 

Objective
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

Study design
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.  

Study population

All patients, indicated for a first IVF/ICSI treatment cycle at one of the participating hospitals.

Intervention

Office Hysteroscopy

 

Outcome measures

Primary

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


Time schedule

01-04-2011 to 01-01-2015

Projectleaders
Dr. F.J.M. Broekmans, UMCUtrecht, divisie Vrouw en Baby.


Subsidy
ZonMW

 

Protocol

INSIGHT protocol 27-01-10 (pdf)

 

Contact

Dr. Helen Torrance

UMC Utrecht, Afd Voortplantingsgeneeskunde

F05.126,

Postbus 85500

3508 GA  Utrecht, Nederland

Tel. 088 7555 555 sein4296

h.torrance@umcutrecht.nl