Recurrent Implantation FailureNCT07641088
Zishen Yutai Pill for Patients With Recurrent Implantation Failure
A study testing Zishen Yutai Pill in people with Recurrent Implantation Failure, run by Peking University Third Hospital at 13 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Recurrent Implantation Failure
- What is being tested?
- Zishen Yutai Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 878 participants
- Where
- 13 sitesChina
- Study dates
- 1 Jul 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Rong Li, +86 13701085402, roseli001@sina.com
Rong Li
Peking University People's Hospital
Beijing, Beijing Municipality
Li Tian, +86-010-88324436, Tianli916916@126.com
Li Tian
Xiangya Hospital of Central South University
Changsha, Hunan
Yanping Li, +86-0731-89752849, lisayanping@sina.com
Yanping Li
Sichuan Jinxin Xinan Women and Children's Hospital (Bisheng)
Chengdu, Sichuan
Xingyu Lv, +86-028-65118868, lxyy323@163.com
Xingyu Lv
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Yuhua Shi, +86-020-62787614, shiyuhua2003@126.com
Yuhua Shi
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Hui Chen, +86-020-81332233, zheling76@163.com
Hui Chen
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Limin Wu, +86-0551-62283402, wuliminmall@126.com
Limin Wu
Jiangsu Province Hospital
Nanjing, Jiangsu
Feiyang Diao, +86-025-68302608, phenix_y@163.com
Feiyang Diao
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality
Qifeng Lv, +86-021-63138341, Lyuqifenf@126.com
Qifeng Lv
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Guimin Hao, +86-0311-66002721, Haoguimin@163.com
Guimin Hao
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Haiyan Yang, +86-0577-88069520, 13957720491@163.com
Haiyan Yang
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi
Haiyan Wang, +86-029-85323432, bistory@mail.xjtu.edu.cn
Haiyan Wang
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yungai Xiang, +86-0371-63974718, xiangyungai2063@126.com
Yungai Xiang
About this study
Official title: 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.
Read more
Participants will:
- 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.
- 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.
- Conditions
- Recurrent Implantation Failure
- Being tested
- Zishen Yutai Pill, Placebo
- Keywords
- traditional Chinese medicine, Zishen Yutai pill, recurrent implantation failure, frozen-thawed embryo transfer, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zishen Yutai PillDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ZYP group | Experimental | Zishen Yutai Pill, 5g per time, three times daily Receives: Drug: Zishen Yutai Pill |
| Placebo group | Placebo comparator | Placebo, 5g per time, three times daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth is defined as delivery of any viable infants after 28 weeks of gestation.
Measured: 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)
Natural cycle and hormone replacement therapy (HRT) cycle are two endometrial preparation methods before frozen embryo transfer.
Measured: 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)
Natural cycle and hormone replacement therapy (HRT) cycle are two endometrial preparation methods before frozen embryo transfer.
Measured: 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)
Measured: On the day of embryo transfer, about 6-7 weeks after enrollment.
Endometrial pattern (embryo transfer day)
Measured: On the day of embryo transfer, about 6-7 weeks after enrollment.
β-HCG positive rate
Serum β-HCG level ≥ 20 IU/L at 2 weeks after embryo transfer is defined as positive.
Measured: At 2 weeks after embryo transfer, about 8 weeks after enrollment.
Implantation rate
Implantation rate is defined as the number of gestational sacs per the number of embryos transferred.
Measured: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Clinical pregnancy rate
Clinical pregnancy is defined as the presence of intrauterine gestation sac under transvaginal ultrasonography.
Measured: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Ongoing pregnancy rate
Ongoing pregnancy is defined as pregnancy with live fetus beyond 10 weeks after embryo transfer (approximately 12 weeks of gestation).
Measured: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Biochemical pregnancy loss rate
Biochemical pregnancy loss is defined as a positive serum β-HCG test with no evidence of a gestational sac on subsequent ultrasound.
Measured: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Clinical pregnancy loss rate
Clinical pregnancy loss is defined as the failure of a confirmed clinical pregnancy to progress to live birth.
Measured: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Gestational age at delivery
Measured: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Birthweight
Measured: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Rate of adverse events
Measured: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Implantation FailureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 878 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Rong, Peking University Third Hospital
- Investigators
- Rong Li, MD, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641088
- Sponsor's protocol ID
- BYSZYYY.ZSYTW-HBT-2026
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be provided as supplementary materials upon publication in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zishen Yutai Pill for Patients With Recurrent Implantation Failure: a Randomized, Double-blind, Parallel-group, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07641088
- Acronym / sponsor ID
- BYSZYYY.ZSYTW-HBT-2026
- Conditions
- Recurrent Implantation Failure
- Keywords
- traditional Chinese medicine, Zishen Yutai pill, recurrent implantation failure, frozen-thawed embryo transfer, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 878 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZYP group | Experimental | Drug: Zishen Yutai PillZishen Yutai Pill, 5g per time, three times daily |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo, 5g per time, three times daily |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zishen Yutai PillEligible 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 | ZYP group |
| PlaceboEligible 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. | Drug | Placebo group |
Primary outcome
Live birth rate
Time frame: 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.
13 secondary outcomes
Endometrial thickness (ovulation day/endometrial transformation day)
Time frame: 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)
Time frame: 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)
Time frame: On the day of embryo transfer, about 6-7 weeks after enrollment.
Endometrial pattern (embryo transfer day)
Time frame: On the day of embryo transfer, about 6-7 weeks after enrollment.
β-HCG positive rate
Time frame: At 2 weeks after embryo transfer, about 8 weeks after enrollment.
Implantation rate
Time frame: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Clinical pregnancy rate
Time frame: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Ongoing pregnancy rate
Time frame: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Biochemical pregnancy loss rate
Time frame: At 5 weeks after embryo transfer, about 11 weeks after enrollment.
Clinical pregnancy loss rate
Time frame: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Gestational age at delivery
Time frame: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Birthweight
Time frame: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Rate of adverse events
Time frame: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be provided as supplementary materials upon publication in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong Li, MD, PhD principal investigator
Peking University Third Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zishen Yutai Pill in people with Recurrent Implantation Failure, run by Peking University Third Hospital at 13 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Li (+86 13701085402, roseli001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: About 40 weeks after embryo transfer, up to a maximum duration of 52 weeks after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.