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Zishen Yutai Pill for Patients With Recurrent Implantation Failure

10 de junho de 2026 atualizado por: Li Rong, Peking University Third Hospital

Zishen Yutai Pill for Patients With Recurrent Implantation Failure: a Randomized, Double-blind, Parallel-group, Placebo-controlled Trial

The goal of this clinical trial is to evaluate the efficacy of Zishen Yutai Pill (ZYP) on pregnancy outcomes following embryo transfer and its safety in patients with recurrent implantation failure. The main question it aims to answer is whether ZYP can improve live birth rate in participant's frozen embryo transfer (FET) cycles.

Researchers will compare ZYP to a placebo (a look-alike substance with similar characteristics to ZYP) to see if it works to improve pregnancy outcomes.

Participants will:

  1. Start to receive ZYP or placebo (5g per time, 3 times daily) within the first 5 days of their initial menstrual cycle, and will undergo FET in the following cycle. The medication will be taken without interruption till the day of pregnancy test (2 weeks after embryo transfer). Patients with positive results in β-HCG test will continue to take the drug until clinical pregnancy confirmation by ultrasound three weeks later. For those with a negative β-HCG result, the intervention will be stopped.
  2. Baseline visit will be conducted on days 2-4 of the participant's first menstrual cycle. Subsequent clinic visits will follow the standard protocol for FET cycle, as outlined below:

Visit 1 (days 2-4 of the second menstrual cycle); Visit 2 (day of ovulation or day of endometrial transformation); Visit 3 (day of embryo transfer); Visit 4 (2 weeks after embryo transfer); Visit 5 (5 weeks after embryo transfer). Follow-up is scheduled at 10 weeks after embryo transfer (Visit 6) and after delivery (Visit 7), and these can be conducted remotely.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

878

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contato:
        • Investigador principal:
          • Limin Wu
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital
        • Investigador principal:
          • Rong Li
        • Contato:
      • Beijing, Beijing Municipality, China
        • Peking University People's Hospital
        • Contato:
        • Investigador principal:
          • Li Tian
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Investigador principal:
          • Hui Chen
        • Contato:
      • Guangzhou, Guangdong, China
        • Nanfang Hospital, Southern Medical University
        • Contato:
        • Investigador principal:
          • Yuhua Shi
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Second Hospital of Hebei Medical University
        • Contato:
        • Investigador principal:
          • Guimin Hao
    • Henan
      • Zhengzhou, Henan, China
        • The Second Affiliated Hospital of Zhengzhou University
        • Contato:
        • Investigador principal:
          • Yungai Xiang
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
        • Contato:
        • Investigador principal:
          • Yanping Li
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
        • Contato:
        • Investigador principal:
          • Feiyang Diao
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contato:
        • Investigador principal:
          • Haiyan Wang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Ninth People's Hospital
        • Contato:
        • Investigador principal:
          • Qifeng Lv
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Jinxin Xinan Women and Children's Hospital (Bisheng)
        • Contato:
        • Investigador principal:
          • Xingyu Lv
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • The First Affiliated Hospital of Wenzhou Medical University
        • Investigador principal:
          • Haiyan Yang
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Meet the diagnostic criteria for recurrent implantation failure;
  2. Aged between 20-40 years old (inclusive) when oocytes were retrieved, and <43 at enrollment;
  3. Have at least 1 good-quality embryo for transfer;
  4. Intend to undergo frozen-thawed embryo transfer;
  5. Voluntary participation and signed informed consent.

Exclusion Criteria:

  1. Concomitant unresolved intrauterine lesions (e.g., intrauterine adhesions grade III-IV, endometrial polyps ≥1 cm, acute endometritis), endometriosis (ASRM stage ≥III), or adenomyosis (uterine volume ≥8 weeks of gestation) that affect embryo implantation;
  2. Intend to undergo FET after preimplantation genetic testing (PGT), including aneuploidy screening (PGT-A), monogenic disease testing (PGT-M), chromosomal structural rearrangement testing (PGT-SR);
  3. Thin endometrium (<7 mm) before enrollment;
  4. Concomitant severe genital malformations or genital neoplasms;
  5. Contraindications to estrogen and progestogen (e.g., history of breast cancer);
  6. Presence of medical contraindications to assisted reproductive technology, including that either partner has a severe psychiatric disorder, acute genitourinary tract infection, sexually transmitted disease, serious deleterious habit (e.g., drug abuse), or teratogenic exposure to radiation, toxic agent or medication that still under effect; or genetic diseases specified in the Law of the People's Republic of China on Maternal and Infant Health Care for which childbearing and PGT are contraindicated; or severe somatic diseases incompatible with pregnancy; or chromosomal abnormalities;
  7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × the upper limit of normal (ULN), or serum creatinine (Scr) > ULN;
  8. Presence of poorly controlled severe systemic diseases, including cardiovascular, digestive, endocrine, and autoimmune diseases (e.g., antiphospholipid syndrome, Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis);
  9. Use of traditional Chinese medicines with similar functions and indications to ZYP within 1 month before screening that may affect treatment efficacy. Chinese patent medicines such as Tiaojing Cuyun Pills, Kuntai Capsules, Peikun Pills, Qilin Pills, Jinfeng Pills, Gushen Antai Pills, and Chinese herbal decoctions containing Cuscutae Semen, Dipsaci Radix, Taxilli Herba, and Asini Corii Colla with kidney-tonifying and spleen-strengthening effects;
  10. Allergy to any component of the study drugs;
  11. Participated in another interventional trials within 1 month prior to enrollment;
  12. Deemed unsuitable for this study by the investigator.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: ZYP group
Zishen Yutai Pill, 5g per time, three times daily
Medicamento: Zishen Yutai Pill
Eligible participants start to receive ZYP within the first 5 days of their initial menstrual cycle, and will undergo frozen-thawed embryo transfer (FET) in the following cycle. The medication will be taken without interruption till the day of pregnancy test (two weeks after embryo transfer). Patients with positive results in β-HCG test will continue to take the drug until clinical pregnancy confirmation by ultrasound three weeks later. For those with negative β-HCG results, the intervention will be stopped.
Comparador de Placebo: Placebo group
Placebo, 5g per time, three times daily
Medicamento: Placebo
Eligible participants start to receive placebo within the first 5 days of their initial menstrual cycle, and will undergo frozen-thawed embryo transfer (FET) in the following cycle. The medication will be taken without interruption till the day of pregnancy test (two weeks after embryo transfer). Patients with positive results in β-HCG test will continue to take the drug until clinical pregnancy confirmation by ultrasound three weeks later. For those with negative β-HCG results, the intervention will be stopped.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Live birth rate
Prazo: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Live birth is defined as delivery of any viable infants after 28 weeks of gestation.
About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Endometrial thickness (ovulation day/endometrial transformation day)
Prazo: On the day of ovulation (natural cycle) or on the day of endometrial transformation (HRT cycle), about 6 weeks after enrollment.
Natural cycle and hormone replacement therapy (HRT) cycle are two endometrial preparation methods before frozen embryo transfer.
On the day of ovulation (natural cycle) or on the day of endometrial transformation (HRT cycle), about 6 weeks after enrollment.
Endometrial pattern (ovulation day/endometrial transformation day)
Prazo: On the day of ovulation (natural cycle) or on the day of endometrial transformation (HRT cycle), about 6 weeks after enrollment.
Natural cycle and hormone replacement therapy (HRT) cycle are two endometrial preparation methods before frozen embryo transfer.
On the day of ovulation (natural cycle) or on the day of endometrial transformation (HRT cycle), about 6 weeks after enrollment.
Endometrial thickness (embryo transfer day)
Prazo: On the day of embryo transfer, about 6-7 weeks after enrollment.
On the day of embryo transfer, about 6-7 weeks after enrollment.
Endometrial pattern (embryo transfer day)
Prazo: On the day of embryo transfer, about 6-7 weeks after enrollment.
On the day of embryo transfer, about 6-7 weeks after enrollment.
β-HCG positive rate
Prazo: At 2 weeks after embryo transfer, about 8 weeks after enrollment.
Serum β-HCG level ≥ 20 IU/L at 2 weeks after embryo transfer is defined as positive.
At 2 weeks after embryo transfer, about 8 weeks after enrollment.
Implantation rate
Prazo: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Implantation rate is defined as the number of gestational sacs per the number of embryos transferred.
At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Clinical pregnancy rate
Prazo: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Clinical pregnancy is defined as the presence of intrauterine gestation sac under transvaginal ultrasonography.
At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Ongoing pregnancy rate
Prazo: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Ongoing pregnancy is defined as pregnancy with live fetus beyond 10 weeks after embryo transfer (approximately 12 weeks of gestation).
About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Biochemical pregnancy loss rate
Prazo: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Biochemical pregnancy loss is defined as a positive serum β-HCG test with no evidence of a gestational sac on subsequent ultrasound.
At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Clinical pregnancy loss rate
Prazo: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Clinical pregnancy loss is defined as the failure of a confirmed clinical pregnancy to progress to live birth.
About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Gestational age at delivery
Prazo: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Birthweight
Prazo: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Rate of adverse events
Prazo: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Peking University Third Hospital

Investigadores

  • Investigador principal: Rong Li, MD, PhD, Peking University Third Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2029

Conclusão do estudo (Estimado)

31 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

4 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de junho de 2026

Primeira postagem (Real)

11 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BYSZYYY.ZSYTW-HBT-2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified individual participant data will be provided as supplementary materials upon publication in a peer-reviewed journal.

Prazo de Compartilhamento de IPD

IPD will be shared within two years after publication in a peer-reviewed journal.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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