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Zishen Yutai Pill for Patients With Recurrent Implantation Failure

10 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

878

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chine
    • Anhui
      • Hefei, Anhui, Chine
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contact:
        • Chercheur principal:
          • Limin Wu
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100191
        • Peking University Third Hospital
        • Chercheur principal:
          • Rong Li
        • Contact:
      • Beijing, Beijing Municipality, Chine
        • Peking University People's Hospital
        • Contact:
        • Chercheur principal:
          • Li Tian
    • Guangdong
      • Guangzhou, Guangdong, Chine
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Chercheur principal:
          • Hui Chen
        • Contact:
      • Guangzhou, Guangdong, Chine
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Chercheur principal:
          • Yuhua Shi
    • Hebei
      • Shijiazhuang, Hebei, Chine
        • The Second Hospital of Hebei Medical University
        • Contact:
        • Chercheur principal:
          • Guimin Hao
    • Henan
      • Zhengzhou, Henan, Chine
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
        • Chercheur principal:
          • Yungai Xiang
    • Hunan
      • Changsha, Hunan, Chine
        • Xiangya Hospital of Central South University
        • Contact:
        • Chercheur principal:
          • Yanping Li
    • Jiangsu
      • Nanjing, Jiangsu, Chine
        • Jiangsu Province Hospital
        • Contact:
          • Feiyang Diao
          • Numéro de téléphone: +86-025-68302608
          • E-mail: phenix_y@163.com
        • Chercheur principal:
          • Feiyang Diao
    • Shaanxi
      • Xi'an, Shaanxi, Chine
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
        • Chercheur principal:
          • Haiyan Wang
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine
        • Shanghai Ninth People's Hospital
        • Contact:
        • Chercheur principal:
          • Qifeng Lv
    • Sichuan
      • Chengdu, Sichuan, Chine
        • Sichuan Jinxin Xinan Women and Children's Hospital (Bisheng)
        • Contact:
          • Xingyu Lv
          • Numéro de téléphone: +86-028-65118868
          • E-mail: lxyy323@163.com
        • Chercheur principal:
          • Xingyu Lv
    • Zhejiang
      • Wenzhou, Zhejiang, Chine
        • The First Affiliated Hospital of Wenzhou Medical University
        • Chercheur principal:
          • Haiyan Yang
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: ZYP group
Zishen Yutai Pill, 5g per time, three times daily
Médicament: 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.
Comparateur placebo: Placebo group
Placebo, 5g per time, three times daily
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Live birth rate
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Endometrial thickness (ovulation day/endometrial transformation day)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Peking University Third Hospital

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juin 2026

Première publication (Réel)

11 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BYSZYYY.ZSYTW-HBT-2026

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Délai de partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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