Continuous use of Oral contraceptives as an alternative for long term Pituitary down-regulation with a GnRH agonist prior to IVF/ICSI in Endometriosis patients: a randomised controlled trial

In women suffering from endometriosis, long term pituitary down-regulation for three to six months prior to IVF/ICSI improves clinical pregnancy rates. However, discussion about this treatment strategy exist and uncomfortable side effects are often described. Alternatively, IVF/ICSI pre-treatment with continuously administered oral contraceptives may offer less side-effects, lower (in)direct costs as well as encouraging IVF outcomes in women with endometriosis. Until now, these two different IVF/ICSI pre-treatment strategies in women with severe endometriosis haven’t been directly compared yet. Therefore we planned an open-label, parallel two-arm randomized controlled trial to show a non-inferiority of continuous use of oral contraceptives versus long term pituitary down-regulation with a GnRH agonist prior to IVF/ICSI treatment in patients with severe endometriosis (ASRM stages III and IV).

The continuous use of oral contraceptives for three months
prior to IVF/ICSI treatment will be non-inferior to the use of long term pituitary down-regulation with a GnRH agonist for three months prior to IVF/ICSI treatment in patients with severe endometriosis (ASRM stages III and IV).

Measurement will be performed at baseline and at three, six, nine, twelve and fifteen months after randomization.

After informed consent, eligible women will be randomly allocated to the intervention group (group 1; one-phase oral contraceptive (sub 50 pill) continuously during three subsequent months (i.e.3x28days)) or the reference group (group 2; three Leuprorelin 3.75mg i.m./s.c. depot injections during three subsequent months). Tibolon 2,5mg will be given daily as add back therapy in the reference group. After three months of pre-treatment the IVF/ICSI stimulation phase will be started.