Infertility, FemaleNCT03703700
The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET
A study testing Zishen Yutai Pill in people with Infertility, Female, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 12 sites in China.
Trial summary
To explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility, Female
- 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
- 1,467 participants
- Where
- 12 sitesChina
- Study dates
- 4 Mar 2019to 14 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- infertile women aged ≥35 and ≤42 years;
- intend to undergo IVF/ICSI-ET (GnRH-a long protocol or GnRH-ant protocol);
- BMI<28kg/m2;
- bilateral ovaries exist;
- patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol.
Who cannot join
- repeated implantation failure (previous three times or more IVF/ICSI-ET failure);
- adenomyosis, uterine line constricted by uterine fibroid;
- untreated bilateral hydrosalpinx;
- endometrial diseases that have not been cured ;
- known diseases that are not suitable for undergoing assisted reproductive technology or at the present not suitable for pregnancy;
- patients who have taken traditional Chinese medicine or Chinese patent medicine for infertility treatment in the last month(30 days).
Show all 11Show fewer
- Exit Criteria:
- subjects who have adverse events cannot be tolerated;
- severe breach of the protocol;
- for subjects who exit due to personal or unpredictable reasons, please describe specific details;
- subjects considered inappropriate to continue to participate in the study for other medical reasons.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Reproductive and Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410000
Chongqing Health Center For Women and Children
Chongqing, Chongqing Municipality
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Reproductive Hospital affiliated to Shandong University
Jinan, Shandong
The First Hospital of Lanzhou University
Lanzhou, Gansu
Liuzhou Maternal and Child Healthcare Hospital
Liuzhou, Guangxi
West China Second University Hospital/West China Women's and Children's Hospital
Sichuan, Sichuan
The Affiliated Suzhou Hospital of Nanjing Medical University
Suzhou, Jiangsu
Northwest Women and Children's Hospital
Xi’an, Shanxi
Tangdu Hospital of Air Force Medical University
Xi’an, Shanxi
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: The Application of Zishen Yutai Pill in Aged Women Undergoing in Vitro Fertilization-embryo Transfer: a Multi-center Double-blind Randomized Controlled Trial
To explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.
Read the detailed description
This will be a multi-center double-blind randomized controlled trial, which aims to explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.The target population will be infertile women aged between 35 and 42 years, BMI<28kg/m2 and bilateral ovaries who undergo IVF-ET (long or antagonist protocol). Qualified 1,466 patients are randomized into either of two groups.They will be randomized to receive either Zishen Yutai Pill or the placebo. The pregnancy test results and pregnancy complications will be followed up by checking medical records and telephone calls.
- Conditions
- Infertility, Female
- Being tested
- Zishen Yutai Pill, Placebo
- Keywords
- IVF-ET, infertility, aged, women
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zishen Yutai PillDrug
Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug.
PlaceboDrug
Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug.
| Study group | Role | What they receive |
|---|---|---|
| Zishen Yutai pill group | Experimental | Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. Receives: Drug: Zishen Yutai Pill |
| Placebo group | Placebo comparator | Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. 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 rate=Number of live birth / Paticipants randomized
Measured: 1 year after embryo transfer day, up to a maximum duration of 58 weeks
Secondary outcomes (21)
Number of Retrieved Oocytes
The total number of oocytes retrieved through ultrasound-guided transvaginal aspiration.
Measured: On embryo transfer day, approximately 6 weeks
Rate of Retrieved Oocytes
Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles with a diameter ≥10mm on the HCG injection day.
Measured: On embryo transfer day, approximately 6 weeks
Number of Matured Oocytes Retrieved
The number of oocytes with pronuclei or polar bodies observed on Day 1 after oocyte retrieval in IVF patients, or as the number of MII oocytes on the day of oocyte retrieval in ICSI patients.
Measured: On embryo transfer day, approximately 6 weeks
Rate of Matured Oocytes
Rate of mature oocytes = Number of mature oocytes/Number of retrieved oocytes
Measured: On embryo transfer day, approximately 6 weeks
Number of Cleavage
Number of fertilized oocytes that undergo cleavage on Day 2 after oocyte retrieval.
Measured: On embryo transfer day, approximately 6 weeks
Cleavage Rate
Cleavage rate=Number of all cleaved embryos/Number of fertilized oocytes (2PN+1PN+ multiple PN)
Measured: On embryo transfer day, approximately 6 weeks
Number of Available Embryos
The sum of the number of embryos transferred and the number of embryos frozen.
Measured: On embryo transfer day, approximately 6 weeks
Rate of Available Embryos
Rate of available embryos=Number of available embryos/Number of cleaved oocytes.
Measured: On embryo transfer day, approximately 6 weeks
Number of High-quality Embryos
High-quality embryo will be defined according to the day of embryo transfer, following the Istanbul consensus and Gardner criteria, Day 2: 4 cells, cell fragments <10% and no multi-nucleus; Day 3: 8 cells, cell fragments <10%, no multi-nucleus; Day 5: stage 4 blastocyst, grade A inner cell mass, grade A trophectoderm (12,13).
Measured: On embryo transfer day, approximately 6 weeks
Rate of High-quality Embryos
Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos
Measured: On embryo transfer day, approximately 6 weeks
Biochemical Pregnancy Rate
Biochemical pregnancy rate=Number of positive pregnancy tests/Paticipants randomized
Measured: 14 days after ET day, approximately 8 weeks
Implantation Rate
Implantation rate=Number of gestational sacs/Number of embryos transferred
Measured: five weeks after ET day, approximately 11 weeks
Clinical Pregnancy Rate
The clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancies / Paticipants randomized
Measured: five weeks after ET day, approximately 11 weeks
Miscarriage Rate (Among Positive Pregnancy Test Population)
Miscarriage Rate (among positive pregnancy test population) =Number of miscarriages / Number of biochemical pregnancy
Measured: 1 year after embryo transfer, up to 58 weeks
Miscarriage Rate (Among Clinical Pregnancy Population)
Miscarriage rate (among clinical pregnancy population)=Number of miscarriages / Number of clinical pregnancies
Measured: 1 year after embryo transfer, up to 58 weeks
The Birth Weight of the Newborn
By checking medical records
Measured: 1 year after embryo transfer, up to 58 weeks
The Birth Height of the Newborn
By checking medical records
Measured: 1 year after embryo transfer, up to 58 weeks
Preterm Delivery Among Live Birth
Delivery of a fetus at less than 37 and more than 28 weeks gestational age.
Measured: 1 year after embryo transfer, up to 58 weeks
Low Birth Weight Among Neonates
Neonatal birth weight ≤ 2500 g.
Measured: 1 year after embryo transfer, up to 58 weeks
Congenital Anomalies Among Neonates
Congenital anomalies are defined as structural or functional anomalies that occur during intrauterine life, including minor and major anomalies.
Measured: 1 year after embryo transfer, up to 58 weeks
Neonates Entering NICU
NICU, neonate intensive care unit.
Measured: 1 year after embryo transfer, up to 58 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start4 Mar 2019
- Primary completion14 Sep 2024
- Study completion14 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,467 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongzi Yang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Dongzi Yang, professor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703700
- Sponsor's protocol ID
- 2018112704
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2018
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Gong F, Wang X, Hu L, Li H, Guan Y, Ye H, Fan L, Bai H, Wang Z, Huang W, Ma X, Yang D, Zhang H. Zishen Yutai Pill increased live births in advanced maternal age women: a randomized clinical trial. Nat Commun. 2025 Dec 24;17(1):980. doi: 10.1038/s41467-025-67714-4.
PubMed 41444477
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Zishen Yutai Pill in Aged Women Undergoing in Vitro Fertilization-embryo Transfer: a Multi-center Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03703700
- Acronym / sponsor ID
- 2018112704
- Conditions
- Infertility, Female
- Keywords
- IVF-ET, infertility, aged, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,467 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 14 Sep 2024 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.
Detailed description
This will be a multi-center double-blind randomized controlled trial, which aims to explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.The target population will be infertile women aged between 35 and 42 years, BMI<28kg/m2 and bilateral ovaries who undergo IVF-ET (long or antagonist protocol). Qualified 1,466 patients are randomized into either of two groups.They will be randomized to receive either Zishen Yutai Pill or the placebo. The pregnancy test results and pregnancy complications will be followed up by checking medical records and telephone calls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zishen Yutai pill group | Experimental | Drug: Zishen Yutai PillPatients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
| Placebo group | Placebo comparator | Drug: PlaceboPatients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- infertile women aged ≥35 and ≤42 years;
- intend to undergo IVF/ICSI-ET (GnRH-a long protocol or GnRH-ant protocol);
- BMI<28kg/m2;
- bilateral ovaries exist;
- patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol.
Key exclusion criteria (11 listed)
- repeated implantation failure (previous three times or more IVF/ICSI-ET failure);
- adenomyosis, uterine line constricted by uterine fibroid;
- untreated bilateral hydrosalpinx;
- endometrial diseases that have not been cured ;
- known diseases that are not suitable for undergoing assisted reproductive technology or at the present not suitable for pregnancy;
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 PillPatients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. | Drug | Zishen Yutai pill group |
| PlaceboPatients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug. | Drug | Placebo group |
Primary outcome
Live Birth Rate
Time frame: 1 year after embryo transfer day, up to a maximum duration of 58 weeks
Live birth rate=Number of live birth / Paticipants randomized
21 secondary outcomes
Number of Retrieved Oocytes
Time frame: On embryo transfer day, approximately 6 weeks
Rate of Retrieved Oocytes
Time frame: On embryo transfer day, approximately 6 weeks
Number of Matured Oocytes Retrieved
Time frame: On embryo transfer day, approximately 6 weeks
Rate of Matured Oocytes
Time frame: On embryo transfer day, approximately 6 weeks
Number of Cleavage
Time frame: On embryo transfer day, approximately 6 weeks
Cleavage Rate
Time frame: On embryo transfer day, approximately 6 weeks
Number of Available Embryos
Time frame: On embryo transfer day, approximately 6 weeks
Rate of Available Embryos
Time frame: On embryo transfer day, approximately 6 weeks
Number of High-quality Embryos
Time frame: On embryo transfer day, approximately 6 weeks
Rate of High-quality Embryos
Time frame: On embryo transfer day, approximately 6 weeks
Biochemical Pregnancy Rate
Time frame: 14 days after ET day, approximately 8 weeks
Implantation Rate
Time frame: five weeks after ET day, approximately 11 weeks
Clinical Pregnancy Rate
Time frame: five weeks after ET day, approximately 11 weeks
Miscarriage Rate (Among Positive Pregnancy Test Population)
Time frame: 1 year after embryo transfer, up to 58 weeks
Miscarriage Rate (Among Clinical Pregnancy Population)
Time frame: 1 year after embryo transfer, up to 58 weeks
The Birth Weight of the Newborn
Time frame: 1 year after embryo transfer, up to 58 weeks
The Birth Height of the Newborn
Time frame: 1 year after embryo transfer, up to 58 weeks
Preterm Delivery Among Live Birth
Time frame: 1 year after embryo transfer, up to 58 weeks
Low Birth Weight Among Neonates
Time frame: 1 year after embryo transfer, up to 58 weeks
Congenital Anomalies Among Neonates
Time frame: 1 year after embryo transfer, up to 58 weeks
Neonates Entering NICU
Time frame: 1 year after embryo transfer, up to 58 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41444477Li Y, Gong F, Wang X, Hu L, Li H, Guan Y, Ye H, Fan L, Bai H, Wang Z, Huang W, Ma X, Yang D, Zhang H. Zishen Yutai Pill increased live births in advanced maternal age women: a randomized clinical trial. Nat Commun. 2025 Dec 24;17(1):980. doi: 10.1038/s41467-025-67714-4.
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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. This study is not recruiting at the moment.
Dongzi Yang, professor principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
12 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 Infertility, Female, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 12 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 11 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: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: 1 year after embryo transfer day, up to a maximum duration of 58 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703700, which also lists 1 linked publication.
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 25 Mar 2025.