Successful Corifollitropin Alfa Treatment Resulting in 500 Live-Born Infants to Date

BACKGROUND: Corifollitropin alfa is a new recombinant fertility hormone that is able to initiate and sustain follicular growth for an entire week and replaces seven daily injections of gonadotropins. Accordingly, this is a further improvement of the simplified, patient-centered GnRH antagonist regimen. The development program of corifollitropin alfa consisted of several trials that showed that the drug was safe and efficacious in terms of the number of oocytes obtained and ongoing pregnancy rates. As the ultimate goal of controlled ovarian stimulation (COS) for assisted reproductive technology (ART) is achieving a healthy baby, follow-up protocols have been conducted to assess that the newly developed infertility treatment is safe for pregnant women and their offspring. MATERIALS AND METHOD(S): Information on women who became pregnant in one of six trials completed so far in the corifollitropin alfa development program has been collected through routine assessments. Safety in the offspring was assessed from medical examinations at birth and within 3 months thereafter. Any abnormalities were recorded as adverse events and subsequently adjudicated by an external medical expert as minor or major congenital malformations. RESULT(S): In phase 2 feasibility and dose-finding trials, data were collected on 68 women who became pregnant after being treated with different dosages of corifollitropin alfa. Of these, 64 women gave birth to 76 live-born infants. In large controlled phase 3 trials that applied the optimal corifollitropin alfa doses of 100 and 150 μg for women weighing ≤60 kg and >60 kg, respectively, data were collected on 363 women pregnant after corifollitropin alfa treatment and compared with data on 331 women who became pregnant after rFSH (follitropin beta) treatment. Eventually, 332 women treated with corifollitropin alfa gave birth to 424 live-born babies. In the rFSH treatment group, there were 303 treated women with 370 live-born babies. Pregnancy complications and neonatal characteristics including weight, head circumference, and APGAR scores assessed at birth and follow-up were similar between treatment groups. Evaluation of the incidence of major congenital malformations revealed no difference between the treatment groups. In the controlled trials, major malformations were detected in 4.0% and 5.4% of live-born infants after their mothers were treated with corifollitropin alfa or rFSH, respectively (odds ratio, 0.73; 95% confidence interval, 0.38–1.42). CONCLUSION(S): To date, 500 infants have been born after COS treatment for ART with corifollitropin alfa. The available pregnancy and neonatal follow-up data indicate that this new sustained follicle stimulant is safe for both mothers and their offspring.