Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Women undergoing IVF/ICSI who are candidates for a GnRH-antagonist protocol are randomly assigned 1:1 to oral linzagolix or the standard injectable GnRH antagonist (ganirelix or cetrorelix). A third, non-randomized group of women with a clinical indication for progestin-primed ovarian stimulation (PPOS) - for example, a need for a freeze-all strategy - is enrolled concurrently as a comparator cohort. The randomized comparison (linzagolix vs. injectable antagonist) is the primary, non-inferiority analysis; the PPOS cohort provides an exploratory, non-randomized comparison, analyzed with adjustment for baseline differences.
Visão geral do estudo
Status
Condições
Descrição detalhada
This is a single-center, prospective, randomized, controlled non-inferiority trial with a concurrent non-randomized comparator cohort, conducted at CENTRO AMBRA. Women eligible for a GnRH-antagonist protocol are randomized 1:1 to oral linzagolix or the injectable GnRH antagonist using a computer-generated permuted-block randomization sequence (block size of 4, no stratification); allocation is concealed until treatment initiation. A separate, concurrent cohort of women with a clinical indication for PPOS is enrolled as a non-randomized comparator; because assignment to this cohort reflects clinical criteria, it may differ systematically from the randomized arms - confounding by indication limited to the PPOS comparison. This is addressed through pre-specified multivariable adjustment and, where sample size permits, propensity-score methods; the PPOS comparison is interpreted as an association, the randomized comparison as supporting non-inferiority. As treatment is known to investigators and patients, there is no masking (open-label); oocyte and embryo assessment follows standardized, predefined procedures. A target of 40 participants per group (120 total) was defined based on the pre-specified non-inferiority margin of 2.0 MII oocytes. All participants undergo a routine clinical follow-up visit 5 days after oocyte pick-up."
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female, aged 18 to 42 years
- Indication for IVF/ICSI with controlled ovarian stimulation at CENTRO AMBRA
- Population unselected for ovarian reserve (normal, poor, and high responders are eligible)
- Written informed consent, including consent for off-label use of linzagolix and for data processing
- For the two antagonist arms (Linzagolix and Injectable GnRH Antagonist): acceptance of randomization
Exclusion Criteria:
- Known contraindications or hypersensitivity to the study drugs
- Uterine pathology relevant to the study outcome (e.g., uterine malformations, significant submucosal fibroids)
- Contraindications to pregnancy or to ovarian stimulation
- Concurrent participation in another interfering interventional study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: A - Linzagolix
|
Description: Linzagolix Type: Drug Group: A Description: Linzagolix 200 mg administered orally once daily, started per center protocol (fixed stimulation day or upon appearance of the dominant follicle) and continued through the day of trigger. Investigational off-label use for suppression of the premature LH surge during controlled ovarian stimulation. |
|
Comparador Ativo: B - Injectable GnRH Antagonist (Ganirelix/Cetrorelix)
|
Ganirelix Type: Drug Group: B Description: Ganirelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation. Cetrorelix Type: Drug Arm: B Description: Cetrorelix acetate 0.25 mg administered by daily subcutaneous injection, per fixed or flexible protocol according to center practice, to suppress the premature LH surge during controlled ovarian stimulation. |
|
Comparador Ativo: C - PPOS (Progestin-Primed Ovarian Stimulation) Cohort
|
This is a non-randomized, concurrently enrolled comparator cohort (not part of the 1:1 randomization). Medroxyprogesterone Acetate - Type: Drug - Arm: C - Description: Medroxyprogesterone acetate 10 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. Micronized Progesterone - Type: Drug - Arm: C - Description: Micronized progesterone 100-200 mg/day administered orally from stimulation day 1-2 through the day of trigger, as part of a progestin-primed ovarian stimulation (PPOS) protocol with mandatory freeze-all strategy. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Mature (MII) Oocytes Retrieved
Prazo: At oocyte retrieval, approximately 36 hours after trigger (first study cycle)
|
Number of metaphase II (mature) oocytes collected at oocyte retrieval. Non-inferiority of linzagolix versus the injectable GnRH antagonist will be concluded if the lower bound of the 95% confidence interval for the adjusted mean difference in MII oocytes (adjusted for ovarian reserve, age, BMI, gonadotropin type and dose, and trigger type) excludes a loss greater than the pre-specified non-inferiority margin of 2.0 MII oocytes. An exploratory comparison with the PPOS cohort is also performed, adjusted for baseline confounders. |
At oocyte retrieval, approximately 36 hours after trigger (first study cycle)
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Incidence of Premature LH Rise
Prazo: From initiation of LH-suppressive treatment to the day of trigger (up to approximately 12 days)
|
From initiation of LH-suppressive treatment to the day of trigger (up to approximately 12 days)
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Genitais Femininas
- Infertilidade
- Infertilidade Feminina
- Hormônios
- Hormônios, substitutos hormonais e antagonistas hormonais
- Compostos policíclicos
- Pregnas
- Esteróides
- Compostos de anel fundido
- Hormônios esteróides gonadais
- Hormônios gonadais
- Greattenenes
- Gestenos
- Medroxyprogesterona
- Hidroxiprogesteronas
- Hormônios do luto de corpus
- Progesterona congêneres
- Acetato de Medroxiprogesterona
- Progesterona
- Ganirelix
- Cetrorelix
- linzagolix
Outros números de identificação do estudo
- LINZA-COS
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