Efficacy, safety, and immunogenicity of a biosimilar recombinant human follicle-stimulating hormone (Folitime®) vs. Gonal-f® in women undergoing ovarian stimulation for IVF: A randomized, multicenter, evaluator-blinded, non-inferiority study.

OBJECTIVE: We compared the efficacy, safety, and immunogenicity of a biosimilar recombinant human follicle-stimulating hormone (Folitime®) with Gonal-f® in women undergoing ovarian stimulation for in-vitro fertilization. METHODS: This randomized (1:1), multicenter, assessor-blinded, non-inferiority, parallel-group, controlled study conducted at four infertility clinics in Argentina included infertile normogonadotropic women with ages below 39 years, with menstrual cycles of 25/35 days and a body mass index of 18-32 kg/m2 undergoing assisted reproductive technology therapy. During a 5-day fixed-dose phase, the women received 225 IU/day of Folitime® (n=49) or Gonal-f® (n=44), followed by a dose-adaptation phase up to a maximum of 450 IU/day. The non-inferiority margin for oocyte retrieval was estimated at -4 oocytes (one-sided test). Immunogenicity was investigated on days 9 and 84, following the start of treatment. RESULTS: The mean number of oocytes retrieved was 12.6 (SD 7.4) in the Folitime® group and 13.4 (SD 6.9) in the Gonal-f® group (per protocol analysis, 95% confidence interval = -3.82; 2.33), within the non-inferiority margin. Pregnancy rate at week 10 was 24.4% among subjects treated with Folitime® and 19.5% for subjects treated with Gonal-f®. One serious adverse drug reaction-late mild ovarian hyper stimulation syndrome and deep venous thrombosis in the left deep jugular vein-occurred in a subject treated with Folitime®. None of the subjects developed antibodies against the study drugs. There were no unexpected safety findings. CONCLUSIONS: Folitime® is non-inferior to Gonal-f®, with no differences in the safety profile and has been approved as a biosimilar in Argentina.

The adverse effect of overweight in assisted reproduction treatment outcomes.

OBJECTIVE: To assess Body Mass Index (BMI) effects on the results obtained from ICSI cycles. METHODS: We studied 266 ICSI cycles performed between January 2014 and December 2016. The patients were grouped according to their BMI in: Normal (18.5-24.9), Overweight (25.0-29.9) and Obese (>30). We compared the following variables between the groups: number of antral follicles, ovarian stimulation length, gonadotropin dose used, maximum estradiol level, follicles developed/antral follicles, retrieved oocytes/developed follicles and mature/retrieved oocytes, normal fertilization rate, embryo achieved/normal fertilized oocytes, clinical pregnancy and implantation rates. We used the Kruskal-Wallis and the Chi square tests. p<0.05 was considered significant. RESULTS: Normal, Overweight and Obese patients presented comparable values for number of antral follicles (11.6±5.4, 12.5±5.5, 12.2±5.7), ovarian stimulation length (7.5±1.4, 7.6±1.1, 7.8±1.3) and gonadotropin dose used (2043±489, 1940±536, 2109±605). Obese patients had lower values of estradiol (1560±610, 1511±635, 1190±466; p=0.018), developed follicles (81%, 76%, 70%; p<0.0001), and retrieved oocytes (91%, 90%, 84%; p=0.0017); and not significantly lower values of mature oocytes (82%, 82%, 77%; p=0.26). The groups had comparable fertilization rates (72%, 73%, 69%) and embryo achieved rates (67%, 63%, 72%). The normal group had higher, but not significantly higher pregnancy and implantation rates (43%, 40%, 38%, p=0.53; and 33%, 26%, 23%; p=0.11), and significantly higher ongoing pregnancy rates (37%, 33%, 33%, p=0.042). CONCLUSION: Increased BMI patients had impaired ovarian response and lower pregnancy rates in ICSI cycles.

High rate of unintended pregnancy among pregnant women in a maternity hospital in Córdoba, Argentina: a pilot study.

BACKGROUND: Although Argentina has a new law on Reproductive Health, many barriers continue to exist regarding provision of contraceptive methods at public healthcare facilities. METHODS: We asked 212 pregnant women selected at random at the Maternity and Neonatal Hospital, Córdoba, Argentina, to participate in our descriptive study. Women were asked to complete a structured questionnaire. The objectives were to determine the rate of unintended pregnancies, reasons for not using contraception, past history of contraceptive use, and intended future use. RESULTS: Two hundred women responded to the questionnaire. Forty percent of the women stated that they had never used contraception and pregnancy was declared unintended by 65%. In the unintended pregnancy group, almost 50% of women said that they had not been using a contraceptive method because they were "unaware about contraception", and 25% stated that their contraceptive method had failed. Almost 85% of women stated that they intended to use contraception after delivery. CONCLUSION: Approximately two-thirds of all pregnancies in this sample were unintended. Although the data is limited by the small sample size, our findings suggest that our government needs to invest in counseling and in improving the availability and access to contraceptive methods.