Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Zishen Yutai Pill for Patients With Recurrent Implantation Failure

10 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

878

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ZYP group
Zishen Yutai Pill, 5g per time, three times daily
Geneesmiddel: 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.
Placebo-vergelijker: Placebo group
Placebo, 5g per time, three times daily
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Live birth rate
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Endometrial thickness (ovulation day/endometrial transformation day)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Peking University Third Hospital

Onderzoekers

  • Hoofdonderzoeker: Rong Li, MD, PhD, Peking University Third Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

4 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

11 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BYSZYYY.ZSYTW-HBT-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

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

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren