• The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET

  NCT03703700

  CompletedInterventionalNot ApplicableUpdated Mar 25, 2025
• Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET

  NCT04872660

  RecruitingInterventionalPhase 4Updated Mar 10, 2026
• Effect of Acupuncture on the Success Rate in Patients With Recurrent Implantation Failure

  NCT07486297

  Not yet recruitingInterventionalNot ApplicableUpdated Jun 25, 2026
• Platelet Rich Plasma for Patients With Recurrent Implantation Failure

  NCT03379649

  CompletedInterventionalEarly Phase 1Updated Dec 22, 2023
• Effects of Different Acupuncture Techniques on the Success Rate in Patients With Recurrent Implantation Failure

  NCT07669623

  Not yet recruitingInterventionalNot ApplicableUpdated Aug 26, 2026
• Comparing FET Guided by ERA Vs Standard Timing in Patients with Recurrent Implantation Failure

  NCT06762626

  RecruitingInterventionalNot ApplicableUpdated Mar 26, 2025

ClinicalTrials.gov ID

NCT07641088

Lead Sponsor

Peking University Third HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

878Estimated

Last Update Posted

Jun 11, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

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

Brief Summary

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.

• Recurrent Implantation Failure

• Zishen Yutai Pill
• Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Peking University Third HospitalOTHER

phenix_y@163.com+86-025-68302608