This pilot study compared the efficacy and safety of two simple dosing algorithms, one based on anti-Müllerian Hormone (AMH) and the other on the antral follicle count (AFC), to determine the starting dose of recombinant FSH (rFSH) for ovarian stimulation in 348 women. Patients were randomized to a predefined AMH- or AFC-based algorithm. The proportion of cycles with the desired response was similar when rFSH dose was determined using AMH or AFC (35.2% versus 28.4%). There was a significant difference between the groups in the proportion of cycles with a hyperresponse (8.6% and 17.4%, but the incidence of ovarian hyperstimulation syndrome was similar (1.1% and 4.6%). There were no significant differences between two groups in outcomes, including implantation (19.3% versus 19.0%), clinical pregnancy (38.0% versus 46.9%), multiple pregnancy (16.5% versus 15.2%) and miscarriage (7.0% versus 8.3%). However, statistically significant differences in ovarian response were evident among the AMH and AFC subgroups: for AMH, Desired and Hypo; for AFC, Hypo and Hyper. This pilot study provides information for developing protocols to further validate the use of either AMH or AFC to guide the starting dose of rFSH in ovarian stimulation. The ideal outcome for couples undergoing IVF treatment is the birth of a healthy baby. One factor that might influence this is retrieving an adequate number of eggs, which are obtained using various treatment protocols. A group of drugs called gonadotrophins have been used for more than 20years to stimulate the ovaries to produce eggs. However, the dose to start treatment has not been clearly defined. A few studies have looked at ways to use the best gonadotrophin dose for each woman, but to be useful in the clinic any approach needs to be simple and easy to use. This study compared the effectiveness and safety of two simple approaches to determining the starting dose of recombinant FSH (rFSH) for ovarian stimulation in women undergoing IVF. One was based on the concentration of a hormone secreted by developing eggs (anti-Müllerian hormone; AMH) and the other on the number of developing follicles (antral follicle count; AFC). The number of cycles achieving the desired response in terms of number of eggs was similar when rFSH dose was guided using AMH or AFC, and the incidence of ovarian hyperstimulation syndrome was also similar. In addition, rates of clinical pregnancy, multiple pregnancy and miscarriage did not differ between the two groups. However, patients with low AMH concentrations or low AFC had a poor response to ovarian stimulation. This pilot study provides useful information from which new studies can further assess these approaches to personalizing treatment during IVF.
The aim of this study was to assess the effectiveness and safety of a low-dose step-up protocol with a recombinant FSH starting dose of 25 IU for ovulation induction in anovulatory patients with polycystic ovary syndrome (PCOS) and a normal or low body mass index (BMI). In this prospective, non-comparative, open trial, 183 PCOS patients who had three unsuccessful cycles of ovulation induction with clomiphene citrate received recombinant FSH (Puregon((R))) 25 IU/day for 14 days, the dose was then increased by 25 IU every 5 days if there was no follicle of >12 mm diameter (maximum 150 IU/day). Human chorionic gonadotrophin was administered when the lead follicle was >/=18 mm, and intrauterine insemination was performed 36 h later. Duration of stimulation was 15.9 +/- 4.8 days and total FSH dose was 484 +/- 257 IU. A developing follicle was observed in 96.7% of cycles, of which 62.1% had unifollicular development and 15.8% were cancelled due to over-response. The clinical and ongoing pregnancy rates were 35.5% and 33.9%, respectively. There were no multiple pregnancies, and only one case of mild ovarian hyperstimulation syndrome. A low-dose step-up protocol with a recombinant FSH starting dose of 25 IU/day is effective and safe in anovulatory Vietnamese PCOS patients with a low or normal BMI.
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