NCT03703700

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,467

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2024

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 25, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

August 5, 2018

Results QC Date

December 5, 2024

Last Update Submit

March 11, 2025

Conditions

Infertility, Female

Keywords

IVF-ETinfertilityagedwomen

Outcome Measures

Primary Outcomes (1)

  • Live Birth Rate

    Live birth rate=Number of live birth / Paticipants randomized

    1 year after embryo transfer day, up to a maximum duration of 58 weeks

Secondary Outcomes (21)

  • Number of Retrieved Oocytes

    On embryo transfer day, approximately 6 weeks

  • Rate of Retrieved Oocytes

    On embryo transfer day, approximately 6 weeks

  • Number of Matured Oocytes Retrieved

    On embryo transfer day, approximately 6 weeks

  • Rate of Matured Oocytes

    On embryo transfer day, approximately 6 weeks

  • Number of Cleavage

    On embryo transfer day, approximately 6 weeks

  • +16 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

Zishen Yutai pill group
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.

Placebo group

Eligibility Criteria

Age35 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Chongqing Health Center For Women and Children

Chongqing, Chongqing Municipality, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

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

Guangzhou, Guangdong, 510000, China

Location

Liuzhou Maternal and Child Healthcare Hospital

Liuchow, Guangxi, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Reproductive and Genetic Hospital of CITIC-XIANGYA

Changsha, Hunan, 410000, China

Location

The Affiliated Suzhou Hospital of Nanjing Medical University

Suzhou, Jiangsu, China

Location

Reproductive Hospital affiliated to Shandong University

Jinan, Shandong, China

Location

Northwest Women and Children's Hospital

Xi’an, Shanxi, China

Location

Tangdu Hospital of Air Force Medical University

Xi’an, Shanxi, China

Location

West China Second University Hospital/West China Women's and Children's Hospital

Sichuan, Sichuan, China

Location

Related Publications (1)

  • 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. doi: 10.1038/s41467-025-67714-4. Online ahead of print.

    PMID: 41444477DERIVED

MeSH Terms

Conditions

Infertility, FemaleInfertility

Interventions

Zishen Yutai

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
Dr. Dongzi Yang
Organization
Center for Reproductive Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
yangdz@mail.sysu.edu.cn
8602081332233

Study Officials

  • Dongzi Yang, professor

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor，Chief Physician，doctoral supervisor

Study Record Dates

First Submitted

August 5, 2018

First Posted

October 12, 2018

Study Start

March 4, 2019

Primary Completion

September 14, 2024

Study Completion

September 14, 2024

Last Updated

March 25, 2025

Results First Posted

March 25, 2025

Record last verified: 2025-03

Locations

CN(12)