EP11.01: An attempt to reduce the costs of assisted reproductive techniques: a pilot randomised controlled trial: EP11.01: An attempt to reduce the costs of assisted reproductive techniques: a pilot randomised controlled trial

To assess the feasibility of a novel low cost ART treatment – low-cost controlled ovarian stimulation (COS) followed by sperm-egg transfer – aiming at the development of a larger RCT; to evaluate treatment effect and safety through the number of oocytes retrieved and its reproductive outcomes (clinical pregnancy and live birth rates). Quantitative and adaptive pilot randomised trial, with parallel 1:1 allocation in groups. Patients were submitted to a novel low-cost ovarian stimulation protocol (clomiphene citrate + human menopausal gonadotropin + late follicular phase human chorionic gonadotropin). Intervention group was submitted to intrauterine sperm-egg transfer, performed on the day of oocyte retrieval; control group was submitted to IVF and cleavage embryo transfer (IVF-ET). 40 patients were enrolled: 22 were submitted to sperm-egg transfer and 18 to IVF-ET. The median number of oocytes retrieved was 3. The overall clinical pregnancy rate was 7.5%: 4.5% in the intervention group and 11.1% in the IVF-ET. No live birth was achieved in intervention group. In the IVF-ET group, there were two singleton clinical pregnancies that ended up in two live births. Study protocol was prematurely interrupted due to unacceptably low pregnancy rates. The evaluated low-cost ovarian stimulation protocol yields a number of oocytes congruent with those from mild ovarian stimulation, but pregnancy rates were unacceptably low. The potential negative impact of clomiphene citrate on endometrial thickness might be questioned. The sperm-egg transfer intervention could not be properly evaluated by the present study. For an adequate evaluation of this procedure, using another controlled ovarian stimulation is needed. No other trial component needs amendments.