A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol

Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation. In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 mu g corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol. The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9% for the corifollitropin alfa group and 38.1% for rFSH were achieved, with an estimated non-significant difference of 0.9% [95% confidence interval (CI): -3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulus-oocyte-complexes compared with rFSH [estimated difference 1.2 (95% CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7%, respectively P = 0.15). Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800

Ovarian hyperstimulation syndrome in a patient treated with tamoxifen for breast cancer

Objective: To report the management of a rare case of ovarian hyperstimulation syndrome (OHSS) induced by tamoxifen therapy for breast cancer in a 50-year-old woman. Design: Case report. Setting: Gynecology outpatient department of a university hospital. Patient(s): A 50-year-old premenopausal patient with a history of breast cancer was prescribed adjuvant treatment with tamoxifen. Intervention(s): Temporary discontinuation of tamoxifen therapy resolved symptoms, but resumption of tamoxifen caused a recurrence of symptoms. Surgical bilateral salpingo-oophrectomy was therefore performed. Main Outcome Measure(s): Resolution of symptoms of OHSS. Result(s): Bilateral salpingo-oophrectomy rendered the patient postmenopausal and enabled the commencement of the aromatase inhibitor anastrozole as an alternative adjuvant therapy for breast cancer. Conclusion(s): Tamoxifen-induced OHSS is rare. Furthermore, OHSS is very rare in the older female. OHSS usually resolves with temporary discontinuation of tamoxifen, however, the recurrence of symptoms when resuming tamoxifen is better treated with bilateral salpingo-oophorectomy to enable adjuvant treatment with anastrazole. (Fertil Steril (R) 2011; 95: 2429. e5-e7. (C) 2011 by American Society for Reproductive Medicine.