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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.
| Content Provider | Europe PMC |
|---|---|
| Author | Pasqualini, Agustín Ruhlmann, Claudio Botti, Gustavo Angel Estofán, Daniel Eduardo Pasqualini, Sergio Inciarte, Florencia Ruhlmann, Felicitas Lopez, Carla Palena, Celina Klimovsky, Ezequiel Federico, Andrea Gonzalez, Eliseo Cordeiro, Lucas Lago, Nestor |
| Abstract | ObjectiveWe 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.MethodsThis 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.ResultsThe 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.ConclusionsFolitime® is non-inferior to Gonal-f®, with no differences in the safety profile and has been approved as a biosimilar in Argentina. |
| Related Links | https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC8489821&blobtype=pdf |
| ISSN | 15175693 |
| Journal | JBRA Assisted Reproduction [JBRA Assist Reprod] |
| Volume Number | 25 |
| DOI | 10.5935/1518-0557.20210023 |
| PubMed Central reference number | PMC8489821 |
| Issue Number | 4 |
| PubMed reference number | 34338481 |
| e-ISSN | 15180557 |
| Language | English |
| Publisher | Brazilian Society of Assisted Reproduction |
| Publisher Date | 2021-10-04 |
| Access Restriction | Open |
| Rights License | This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivative License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium provided the original work is properly cited and the work is not changed in any way. |
| Subject Keyword | biosimilar recombinant FSH Folitime® Gonal-f® in-vitro fertilization |
| Content Type | Text |
| Resource Type | Article |
| Subject | Obstetrics and Gynecology |
