Understanding the burden of ovarian stimulation: fertility expert and patient perceptions.

This multinational, interview-based study was conducted to provide insights into participants' experiences, behaviour, attitudes and emotions towards fertility treatments. One study group comprised 185 patients who were undergoing ovarian stimulation for IVF while the other comprised 170 physician and nurse fertility experts. A key study objective was to identify which aspects of ovarian-stimulation treatment contribute to the physical and psychological burden on patients. Ovarian-stimulation treatment was considered by 55% (n = 102) of patients to impact upon daily life, while 31% (n = 57) felt that daily injections limited their everyday activities. The most frequent questions from patients to physicians and nurses concerned fertility drug-related side effects, followed by concerns about how to perform their injections. More than half of patients (57%, n = 106) had concerns about the injection process. Within the fertility expert group, almost half (47%, n = 80) expressed concern about whether their patients injected themselves correctly, with 26% (n = 44) raising concerns about patient compliance. This study adds to the growing body of literature on the impact of ovarian stimulation on patients' lives and highlights areas in which improved patient education could help to reduce the psychological burden of IVF treatment.

Improving clinical understanding of the effect of ovarian stimulation on women's lives.

A conceptual model was developed of the impact of ovarian stimulation on women's functioning and wellbeing. A patient-reported outcome (PRO) measure was generated based on this model. Qualitative measures used comprised a discussion guide and coding system devised according to the Food and Drug Administration guidelines for developing PRO measures. Data were gathered through telephone and face-to-face interviews and focus groups. A total of 47 women across nine fertility healthcare providers in France, UK and USA were included in the analysis. The mean age of patients was 35 years (range 24-44). Based on data collected and prior postulated domains, a conceptual model of the impact of ovarian stimulation was developed. Three major (psychological, interference in daily life, logistics) and one minor (side effects) domain were identified. Short-term consequences included problems with psychological health and productivity. Longer term consequences included depression and poor self-image. Factors that modified the impact of ovarian stimulation were also identified. This is the first model providing insight into the impact of ovarian stimulation on women's functioning and wellbeing. Once validated, it can be applied in quantitative research to improve understanding of the impact of ovarian stimulation, and assist in developing more patient-centred approaches to treatment.

Follitropin-beta administered by pen device has superior local tolerance compared with follitropin-alpha administered by conventional syringe.

A receiver- and assessor-blind, randomized, single-centre, crossover study was performed in 60 healthy women volunteers, to compare the local tolerance of two recombinant FSH preparations administered by a pen device (delivering 150 IU follitropin-beta) or by conventional syringe (delivering 150 IU follitropin-alpha). Volunteers were randomized to one of two treatment sequences: pen device followed by conventional syringe, or the reverse. Each preparation was injected once, subcutaneously in the umbilical region and local tolerance reactions were assessed within 5 min, at 1 and 24 h after each administration. In addition, subjects were asked to rate the pain experienced during a period of 24 h after each injection by means of a visual analogue scale (VAS). At administration (within 5 min), severe to moderate pain was experienced in 70.0% of subjects injected by the conventional syringe, whereas only 21.7% of subjects treated with the pen device experienced pain. This difference was highly significant (P

A prospective, randomized clinical trial comparing 150 IU recombinant follicle stimulating hormone (Puregon((R))) and 225 IU highly purified urinary follicle stimulating hormone (Metrodin-HP((R))) in a fixed-dose regimen in women undergoing ovarian stimulation.

A prospective, randomized, open, multicentre (n = 3) study was conducted to compare the efficacy and efficiency of a fixed daily dose of 150 IU (3x50 IU) recombinant follicle stimulating hormone (recFSH, Puregon((R))) and 225 IU (3x75 IU) highly purified urinary FSH (uFSH-HP, Metrodin-HP((R))) in women undergoing ovarian stimulation prior to in-vitro fertilization treatment. A total of 165 women were treated with FSH, 83 subjects with recFSH and 82 subjects with uFSH-HP. In the recFSH group a mean number of 8.8 oocytes were retrieved, compared with 9.8 in the uFSH-HP group (not statistically significant). In the recFSH group, a significantly lower total dose was required compared to the uFSH-HP group, 1479 versus 2139 IU, respectively (P < 0.0001; 95% confidence interval -747 to -572). Treatment with recFSH resulted in a significantly higher embryo development rate (69.6 versus 56.2%; P = 0.003) and more embryos accessible for the embryo freezing programme (3.3 versus 2.0; P = 0.02) compared to uFSH-HP. The vital pregnancy rate per cycle started was 30.2 versus 28.3% in the recombinant and urinary FSH group, respectively. It is concluded that treatment outcome of a fixed daily dose of 150 IU recFSH is comparable to a fixed daily dose of 225 IU uFSH-HP. However, a significantly lower total dose was needed in the recFSH group (nearly 700 IU less).

Cryopreservation: the practicalities of evaluation.

An attempt was made to integrate data from cryopreserved embryos with those from fresh embryos to obtain a realistic assessment of the role of cryopreservation in assisted reproductive treatment. Principles were applied to previously published data from a large prospective randomized multicentre study comprising recombinant and urinary follicle stimulating hormone in in-vitro fertilization.