Zishen Yutai Pill for Patients With Recurrent Implantation Failure

NCT07641088 | Not Yet Recruiting DMC

• 1 other identifier: BYSZYYY.ZSYTW-HBT-2026
• Study Type: interventional
• Target: 878
• Locations: 1 country
• Sites: 13

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. 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. 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:

Conditions

Recurrent Implantation Failure

Keywords

traditional Chinese medicine; Zishen Yutai pill; recurrent implantation failure; frozen-thawed embryo transfer; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  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.

Secondary Outcomes (13)

• Endometrial thickness (ovulation day/endometrial transformation day)

  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)

  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)

  On the day of embryo transfer, about 6-7 weeks after enrollment.

• Endometrial pattern (embryo transfer day)

  On the day of embryo transfer, about 6-7 weeks after enrollment.

• β-HCG positive rate

  At 2 weeks after embryo transfer, about 8 weeks after enrollment.

Study Arms (2)

ZYP group

EXPERIMENTAL

Zishen Yutai Pill, 5g per time, three times daily

Drug: Zishen Yutai Pill

Placebo group

PLACEBO COMPARATOR

Placebo, 5g per time, three times daily

Drug: Placebo

Interventions

Zishen Yutai Pill DRUG

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.

ZYP group

Placebo DRUG

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.

Placebo group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;
• 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);
• Thin endometrium (\<7 mm) before enrollment;
• Concomitant severe genital malformations or genital neoplasms;
• Contraindications to estrogen and progestogen (e.g., history of breast cancer);
• 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;
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 × the upper limit of normal (ULN), or serum creatinine (Scr) \> ULN;
• 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);
• 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;
• Allergy to any component of the study drugs;
• Participated in another interventional trials within 1 month prior to enrollment;
• Deemed unsuitable for this study by the investigator.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (13)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Location

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Location

Sichuan Jinxin Xinan Women and Children's Hospital (Bisheng)

Chengdu, Sichuan, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Zishen Yutai

Study Officials

• Rong Li, MD, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Li

CONTACT

+86 13701085402; roseli001@sina.com

Xiaoyu Long

CONTACT

+86-010-82264816; doralonger@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Third Hospital, Director of the Department of Reproductive Medicine, Deputy Chair of the Department of Obstetrics and Gynecology, Peking University

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be shared within two years after publication in a peer-reviewed journal.

Locations

CN (13)