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

March 11, 2025 updated by: Dongzi Yang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1467

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Chongqing Health Center for Women and Children
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    • Guangxi
      • Liuzhou, Guangxi, China
        • Liuzhou Maternal and Child Healthcare Hospital
    • Henan
      • Zhengzhou, Henan, China
        • The first affiliated hospital of Zhengzhou university
      • Zhengzhou, Henan, China
        • The Third Affiliated Hospital of Zhengzhou University
    • Hunan
      • Changsha, Hunan, China, 410000
        • Reproductive and Genetic Hospital of CITIC-XIANGYA
    • Jiangsu
      • Suzhou, Jiangsu, China
        • The Affiliated Suzhou Hospital of Nanjing Medical University
    • Shandong
      • Jinan, Shandong, China
        • Reproductive Hospital Affiliated to Shandong University
    • Shanxi
      • Xi'an, Shanxi, China
        • Northwest Women and Children's Hospital
      • Xi'an, Shanxi, China
        • Tangdu Hospital of Air Force Medical University
    • Sichuan
      • Sichuan, Sichuan, China
        • West China Second University Hospital/West China Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zishen Yutai pill group
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.
Drug: Zishen Yutai Pill
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.
Placebo Comparator: Placebo group
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.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year after embryo transfer day, up to a maximum duration of 58 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Retrieved Oocytes
Time Frame: On embryo transfer day, approximately 6 weeks
The total number of oocytes retrieved through ultrasound-guided transvaginal aspiration.
On embryo transfer day, approximately 6 weeks
Rate of Retrieved Oocytes
Time Frame: On embryo transfer day, approximately 6 weeks
Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles with a diameter ≥10mm on the HCG injection day.
On embryo transfer day, approximately 6 weeks
Number of Matured Oocytes Retrieved
Time Frame: On embryo transfer day, approximately 6 weeks
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.
On embryo transfer day, approximately 6 weeks
Rate of Matured Oocytes
Time Frame: On embryo transfer day, approximately 6 weeks
Rate of mature oocytes = Number of mature oocytes/Number of retrieved oocytes
On embryo transfer day, approximately 6 weeks
Number of Cleavage
Time Frame: On embryo transfer day, approximately 6 weeks
Number of fertilized oocytes that undergo cleavage on Day 2 after oocyte retrieval.
On embryo transfer day, approximately 6 weeks
Cleavage Rate
Time Frame: On embryo transfer day, approximately 6 weeks
Cleavage rate=Number of all cleaved embryos/Number of fertilized oocytes (2PN+1PN+ multiple PN)
On embryo transfer day, approximately 6 weeks
Number of Available Embryos
Time Frame: On embryo transfer day, approximately 6 weeks
The sum of the number of embryos transferred and the number of embryos frozen.
On embryo transfer day, approximately 6 weeks
Rate of Available Embryos
Time Frame: On embryo transfer day, approximately 6 weeks
Rate of available embryos=Number of available embryos/Number of cleaved oocytes.
On embryo transfer day, approximately 6 weeks
Number of High-quality Embryos
Time Frame: On embryo transfer day, approximately 6 weeks
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).
On embryo transfer day, approximately 6 weeks
Rate of High-quality Embryos
Time Frame: On embryo transfer day, approximately 6 weeks
Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos
On embryo transfer day, approximately 6 weeks
Biochemical Pregnancy Rate
Time Frame: 14 days after ET day, approximately 8 weeks
Biochemical pregnancy rate=Number of positive pregnancy tests/Paticipants randomized
14 days after ET day, approximately 8 weeks
Implantation Rate
Time Frame: five weeks after ET day, approximately 11 weeks
Implantation rate=Number of gestational sacs/Number of embryos transferred
five weeks after ET day, approximately 11 weeks
Clinical Pregnancy Rate
Time Frame: five weeks after ET day, approximately 11 weeks
The clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancies / Paticipants randomized
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 positive pregnancy test population) =Number of miscarriages / Number of biochemical pregnancy
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
Miscarriage rate (among clinical pregnancy population)=Number of miscarriages / Number of clinical pregnancies
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
By checking medical records
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
By checking medical records
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
Delivery of a fetus at less than 37 and more than 28 weeks gestational age.
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
Neonatal birth weight ≤ 2500 g.
1 year after embryo transfer, up to 58 weeks
Congenital Anomalies Among Neonates
Time Frame: 1 year after embryo transfer, up to 58 weeks
Congenital anomalies are defined as structural or functional anomalies that occur during intrauterine life, including minor and major anomalies.
1 year after embryo transfer, up to 58 weeks
Neonates Entering NICU
Time Frame: 1 year after embryo transfer, up to 58 weeks
NICU, neonate intensive care unit.
1 year after embryo transfer, up to 58 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dongzi Yang, professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018112704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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