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Zishen Yutai Pill for Patients With Recurrent Implantation Failure

10 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

878

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ZYP group
Zishen Yutai Pill, 5g per time, three times daily
Droga: 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.
Comparatore placebo: Placebo group
Placebo, 5g per time, three times daily
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Live birth rate
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Endometrial thickness (ovulation day/endometrial transformation day)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University Third Hospital

Investigatori

  • Investigatore principale: Rong Li, MD, PhD, Peking University Third Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BYSZYYY.ZSYTW-HBT-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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