Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients (ALFURO-OHSS)
Effect of Albumin and Furosemide Combination for Prevention of Severe Ovarian Hyperstimulation Syndrome in Hyper-Responders Undergoing Intracytoplasmic Sperm Injection Cycles: A Randomized Controlled Trial
This study aims to evaluate whether the combination of Albumin and Furosemide can reduce the risk of Ovarian Hyperstimulation Syndrome in women undergoing intracytoplasmic sperm injection (ICSI) who are at high risk of developing this condition.
Ovarian hyperstimulation syndrome is a potential complication of ovarian stimulation during assisted reproductive techniques, which can lead to symptoms such as abdominal swelling, fluid accumulation, and, in severe cases, hospitalization. Preventing this condition is important to improve patient safety and treatment outcomes.
In this randomized controlled study, eligible women undergoing ICSI were assigned to receive either the combination of albumin and furosemide or standard care. The study compared the occurrence and severity of OHSS between the two groups.
The results of this study may help identify an effective strategy to prevent OHSS and improve the safety of assisted reproductive treatments.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This is a randomized controlled clinical trial conducted in women undergoing intracytoplasmic sperm injection (ICSI) who are at high risk of developing ovarian hyperstimulation syndrome (OHSS). Participants were randomly allocated into study groups to receive either a combination protocol of albumin and furosemide or standard care.
The study was designed to evaluate the effectiveness of this intervention in reducing the incidence and severity of OHSS. Ovarian hyperstimulation syndrome is a potentially serious complication of controlled ovarian stimulation in assisted reproductive techniques and may result in abdominal distension, fluid accumulation, and hospitalization in severe cases.
The Primary Outcome:
• Incidence of moderate and severe OHSS within 14 days post oocyte retrieval
The Secondary Outcomes:
- Incidence of mild OHSS
- Ovarian volume changes
- Serum estradiol levels on trigger day
- Hematocrit levels post retrieval
- Endometrial thickness and vascularity indices
- Hospital admission rate
- Clinical pregnancy rate
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Iraque, 10006
- High Institute for Infertility Diagnosis and ART
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- The inclusion criteria were females aged ≤35 years old, previous history of severe OHSS, AMH> 3.4, antral follicles count ≥22, presence of >18 follicles with a diameter >11 mm at any day of the stimulation cycle, serum estradiol ≥3500 pg/ml at day of hCG trigger, and aspiration of >15 oocytes at day of oocyte pick up.
Exclusion Criteria:
- Any female who does not meet those criteria were excluded
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Control Arm
Participants receive standard luteal phase support only.
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Routine luteal phase support according to institutional protocol.
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Experimental: Albumin + Furosemide
Participants receive intravenous human albumin (20%, 100 mL) immediately after oocyte retrieval, followed by intravenous furosemide (20 mg), in addition to standard luteal phase support.
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Routine luteal phase support according to institutional protocol.
Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.
Intravenous furosemide 20 mg administered after oocyte retrieval.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Ovarian Hyperstimulation Syndrome
Prazo: From oocyte retrieval until 14 days after embryo transfer= 14 days
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Number of participants who develop ovarian hyperstimulation syndrome after ICSI in each study group.
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From oocyte retrieval until 14 days after embryo transfer= 14 days
|
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Incidence of Moderate and Severe Ovarian Hyperstimulation Syndrome
Prazo: Within 14 Days Post Oocyte Retrieval
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Defined according to standard OHSS classification criteria
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Within 14 Days Post Oocyte Retrieval
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of mild OHSS
Prazo: 14 days from ova pick up
|
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14 days from ova pick up
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Wasan A Wasan Adnan Abduhameed, PhD, High Institute for Infertility Diagnosis and ART
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AlNahrainU
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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