RESUMO
OBJECTIVE: We compared the efï¬cacy, 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.
Assuntos
Medicamentos Biossimilares , Adulto , Medicamentos Biossimilares/efeitos adversos , Feminino , Fertilização in vitro , Hormônio Foliculoestimulante Humano/efeitos adversos , Humanos , Indução da Ovulação , Gravidez , Proteínas RecombinantesRESUMO
A woman aged 38 was referred to this center for surrogacy treatment, after subtotal ablation of her uterus due to a severe postpartum hemorrhage. Her hormonal profiles and ovarian structure were normal. The husband proved fertile and semen analysis was normal. The carrier, a woman 39 years old, fertile with two children of her own, and a long bonding friendship with the patient. After hormonal stimulation with gonadotropins and GnRH antagonist, six mature oocytes were obtained. These originated four embryos after in vitro fertilization, three of which were transferred to the carrier, achieving a singleton pregnancy which led to the birth of a normal child, now more than a year old. A lawsuit was filed after birth requesting the baby be registered with the biological parents name. The judge granted the request based on evidence and testimonies provided, international jurisprudence history and specification in Article 19 of the Argentine Constitution: "No inhabitant of the Nation shall be obliged to do what the law does not demand .nor be deprived of what it does not prohibit". This is an almost ideal example of the proceedings in a case of subrogation. However, we must always bear in mind the fact that in our country there is as yet no regulatory framework for these treatments, therefore there is a high probability of conflict.
Assuntos
Fertilização in vitro/legislação & jurisprudência , Ilegitimidade/legislação & jurisprudência , Mães Substitutas/legislação & jurisprudência , Adulto , Argentina , Constituição e Estatutos , Transferência Embrionária , Feminino , Humanos , GravidezRESUMO
Una mujer de 38 años de edad fue derivada a nuestro centro para un tratamiento de maternidad subrogada, por haber sufrido la ablación subtotal de su útero a causa de una hemorragia puerperal grave. Su perfil hormonal y estructura ovárica eran normales. El esposo tenía fertilidad probada y un espermograma normal. La subrogante era una mujer de 39 años, fértil, con dos hijos propios y con un largo vínculo de amistad con la paciente. Luego de una estimulación con gonadotropinas y antagonista de Gn-RH se obtuvieron 6 ovocitos maduros por punción folicular, que originaron 4 embriones por fertilización in vitro. Tres de ellos evolucionaron y fueron transferidos a la subrogante, lográndose un embarazo único que concluyó con el nacimiento de una niña normal que ya tiene dos años cumplidos. Se inició una acción solicitando la inscripción de la beba ya nacida a nombre de los padres procreacionales. El juez finalmente la otorgó basándose en las pruebas y testimonios aportados, los antecedentes en la jurisprudencia internacional, y el hecho de que según el artículo 19 de la Constitución Nacional: "Ningún habitante de la Nación será obligado a hacer lo que no manda la ley, ni privado de lo que ella no prohíbe". Este es un ejemplo casi ideal de cómo se puede desarrollar un caso de subrogación. Sin embargo, hay que tener en cuenta que en nuestro país no existe aún un marco regulatorio para estos tratamientos, por lo que no queda exenta la posibilidad de conflicto.(AU)
A woman aged 38 was referred to this center for surrogacy treatment, after subtotal ablation of her uterus due to a severe postpartum hemorrhage. Her hormonal profiles and ovarian structure were normal. The husband proved fertile and semen analysis was normal. The carrier, a woman 39 years old, fertile with two children of her own, and a long bonding friendship with the patient. After hormonal stimulation with gonadotropins and GnRH antagonist, six mature oocytes were obtained. These originated four embryos after in vitro fertilization, three of which were transferred to the carrier, achieving a singleton pregnancy which led to the birth of a normal child, now more than a year old. A lawsuit was filed after birth requesting the baby be registered with the biological parents name. The judge granted the request based on evidence and testimonies provided, international jurisprudence history and specification in Article 19 of the Argentine Constitution: "No inhabitant of the Nation shall be obliged to do what the law does not demand .nor be deprived of what it does not prohibit". This is an almost ideal example of the proceedings in a case of subrogation .However, we must always bear in mind the fact that in our country there is as yet no regulatory framework for these treatments, therefore there is a high probability of conflict.(AU)
RESUMO
Una mujer de 38 años de edad fue derivada a nuestro centro para un tratamiento de maternidad subrogada, por haber sufrido la ablación subtotal de su útero a causa de una hemorragia puerperal grave. Su perfil hormonal y estructura ovárica eran normales. El esposo tenía fertilidad probada y un espermograma normal. La subrogante era una mujer de 39 años, fértil, con dos hijos propios y con un largo vínculo de amistad con la paciente. Luego de una estimulación con gonadotropinas y antagonista de Gn-RH se obtuvieron 6 ovocitos maduros por punción folicular, que originaron 4 embriones por fertilización in vitro. Tres de ellos evolucionaron y fueron transferidos a la subrogante, lográndose un embarazo único que concluyó con el nacimiento de una niña normal que ya tiene dos años cumplidos. Se inició una acción solicitando la inscripción de la beba ya nacida a nombre de los padres procreacionales. El juez finalmente la otorgó basándose en las pruebas y testimonios aportados, los antecedentes en la jurisprudencia internacional, y el hecho de que según el artículo 19 de la Constitución Nacional: "Ningún habitante de la Nación será obligado a hacer lo que no manda la ley, ni privado de lo que ella no prohíbe". Este es un ejemplo casi ideal de cómo se puede desarrollar un caso de subrogación. Sin embargo, hay que tener en cuenta que en nuestro país no existe aún un marco regulatorio para estos tratamientos, por lo que no queda exenta la posibilidad de conflicto.
A woman aged 38 was referred to this center for surrogacy treatment, after subtotal ablation of her uterus due to a severe postpartum hemorrhage. Her hormonal profiles and ovarian structure were normal. The husband proved fertile and semen analysis was normal. The carrier, a woman 39 years old, fertile with two children of her own, and a long bonding friendship with the patient. After hormonal stimulation with gonadotropins and GnRH antagonist, six mature oocytes were obtained. These originated four embryos after in vitro fertilization, three of which were transferred to the carrier, achieving a singleton pregnancy which led to the birth of a normal child, now more than a year old. A lawsuit was filed after birth requesting the baby be registered with the biological parents name. The judge granted the request based on evidence and testimonies provided, international jurisprudence history and specification in Article 19 of the Argentine Constitution: "No inhabitant of the Nation shall be obliged to do what the law does not demand .nor be deprived of what it does not prohibit". This is an almost ideal example of the proceedings in a case of subrogation .However, we must always bear in mind the fact that in our country there is as yet no regulatory framework for these treatments, therefore there is a high probability of conflict.
Assuntos
Adulto , Feminino , Humanos , Gravidez , Fertilização in vitro/legislação & jurisprudência , Ilegitimidade/legislação & jurisprudência , Mães Substitutas/legislação & jurisprudência , Argentina , Constituição e Estatutos , Transferência EmbrionáriaRESUMO
A woman aged 38 was referred to this center for surrogacy treatment, after subtotal ablation of her uterus due to a severe postpartum hemorrhage. Her hormonal profiles and ovarian structure were normal. The husband proved fertile and semen analysis was normal. The carrier, a woman 39 years old, fertile with two children of her own, and a long bonding friendship with the patient. After hormonal stimulation with gonadotropins and GnRH antagonist, six mature oocytes were obtained. These originated four embryos after in vitro fertilization, three of which were transferred to the carrier, achieving a singleton pregnancy which led to the birth of a normal child, now more than a year old. A lawsuit was filed after birth requesting the baby be registered with the biological parents name. The judge granted the request based on evidence and testimonies provided, international jurisprudence history and specification in Article 19 of the Argentine Constitution: "No inhabitant of the Nation shall be obliged to do what the law does not demand .nor be deprived of what it does not prohibit". This is an almost ideal example of the proceedings in a case of subrogation. However, we must always bear in mind the fact that in our country there is as yet no regulatory framework for these treatments, therefore there is a high probability of conflict.
