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OPTIMIST trial

 

Optimisation of cost effectiveness through individualised FSH Stimulation dosages for IVF treatment

 

Objectives

The present study will assess the cost-effectiveness of routine use of ORTs and subsequent use of individualised FSH dosages in predicted poor and hyper responders as compared to a policy without ORT, using standard dosages of FSH.

 

In addition, we will assess the costs and effects of the following strategies:

- IVF with a fixed dose of 150 U/day gonadotrophins in all couples

- application of ORT in all women, and dose adjustment in case of expected poor or hyperresponse

- application of ORT in all women, and dose adjustment in case of expected poor response

- application of ORT in all women, and dose adjustment in case of expected hyperresponse

 

These data will then be integrated into a decision model that compares cost-effectiveness of the three dose-adjustment strategies to the fixed FSH dose strategy. We will assess the costs and the live birth rates of these strategies. In a sensitivity analysis, we will adjust for different age categories. It should be emphasized that we will study three cycles of IVF, and the cost-effectiveness will be determined for the strategy.

Study design
The study will be designed as a large nationwide multicenter cohort study, with two RCTs embedded in this cohort The cohort will consist of 1,500 women, screened for ovarian capacity by an AFC prior to starting IVF treatment.


Study population

Patients will be recruited from the list of IVF/ICSI indicated couples in 15 hospitals with a special interest in infertility care. Patients eligible for participation in the study will be invited for additional counselling by a research nurse, to ensure that they are fully informed on the nature of the study by means of both oral and written information (Patient Information Form). Patients who agree to participate will be asked to sign a written informed consent of which they will receive a copy.


Outcome measures

Main study parameter/endpoint

Ongoing pregnancy resulting in live birth within 18 months after randomisation. These pregnancies can be obtained in treatment cycles with fresh embryos, as well as in subsequent cryo/thaw cycles after completion of any fresh stimulation cycle. Spontaneous pregnancies between treatment cycles will also be taken into account.

Costs of treatment: direct medical costs, direct non-medical costs and indirect costs (see further in Study Procedures).

 

Secondary study parameters/endpoints

-number of oocytes

- poor response (less than 4 oocytes at retrieval or cancellation due to insufficient follicle growth, i.e. 2 or less dominant follicles sized more than 12 mm growing)

- hyper response (more than 16 oocytes at retrieval or cancellation due to excessive response  as defined above)

- OHSS grade 2 and 3

- cycle cancellation for hyper and poor response, multiple pregnancy, total IU of FSH applied per stimulation cycle.

 

Projectleader
Dr. F.J.M. Broekmans


Subsidy
ZonMW

 

Protocol

OPTIMIST trial protocol (pdf)

 

Contact

Dr. H. Torrance

UMC Utrecht, Afd. Voortplantingsgeneeskunde

F05.126

Postbus 85500

3508 GA Utrecht, Nederland

Tel. 088 -7555 555 sein 4296

h.torrance@umcutrecht.nl