Cost-effectiveness of IUI, IVF and ICSI for male subfertility. The MAle Subfertility Therapy
Effectiveness Rcts.

Rationale:
We hypothesize that less invasive therapies are equally effective as more invasive therapies for male subfertility.

Objective:
In one third of subfertile couples male subfertility is diagnosed. Current treatments for male subfertility, IUI, IVF and ICSI, have, despite their widespread use, not been compared on their cost-effectiveness. The primary aim of this project is to assess the
cost-effectiveness of therapies for male subfertility.
Study design:
IVF versus IUI in moderate male subfertility.

Study population:
Subfertile couples with male subfertility (pre-wash TMSC 3-6 million).

Intervention:
3 cycles of IVF, including transfer of cryoembryos.
Control: 3 cycles of IUI, followed by 3 cycles of IUI-COH. Treatment time horizon 9 months.

Main study parameters/endpoints:
Primary: Ongoing pregnancy leading to live birth.
Secondary: Time to pregnancy, miscarriage, multiple pregnancy, live birth, perinatal outcome, (in-)direct costs, quality of life and patient preferences.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
As we compare interventions that are already applied in current practice, no additional risks or burdens are expected from the study.

To evaluate the cost-effectiveness of therapies for male subfertility.

Primary and secondary outcomes within 9 months after randomisation. Questionnaires at one day, two months, four months and six months after randomization.

3 cycles of IVF, including transfer of cryopreserved embryos vs 3 cycles of IUI, followed by 3 cycles of IUI-COH.