Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07641088

Zishen Yutai Pill for Patients With Recurrent Implantation Failure

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

20 Years - 43 Years

Study Type

INTERVENTIONAL

Enrollment

878

Start Date

2026-07-01

Completion Date

2029-12-31

Last Updated

2026-06-11

Healthy Volunteers

Conditions

Recurrent Implantation Failure

Interventions

DRUG

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.

DRUG

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.

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.

Locations (13)

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

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

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

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

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

Chengdu, Sichuan, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China