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

Primary Purpose

Infertility, Female

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Zishen Yutai Pill
Placebo
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring IVF-ET, infertility, aged, women

Eligibility Criteria

35 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infertile women aged ≥35 and ≤42 years;
  • intend to undergo IVF-ET (long or antagonist 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.

Sites / Locations

  • Chongqing Health Center For Women and Children
  • The First Hospital of Lanzhou University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Liuzhou Maternal and Child Healthcare Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The Third Affiliated Hospital of Zhengzhou University
  • Reproductive and Genetic Hospital of CITIC-XIANGYA
  • Northwest Women and Children's Hospital
  • Tangdu Hospital of Air Force Medical University
  • West China Second University Hospital/West China Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zishen Yutai pill group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
the clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancy cycles / Total number of embryo transfer cycles
Live birth rate
Live birth rate=Number of live birth cycles / Total number of embryo transfer cycles

Secondary Outcome Measures

Serum E2 (Estradiol) concentrations on hCG (human chorionic gonadotrophin) injection day
On the day of hCG injection
Number of retrieved oocytes and zygotes
By medical records
Rate of retrieved oocytes
Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles whose diameter ≥10mm on HCG injection day
Number of cleavage
Zygotes split into more than 2 cells
Cleavage rate
Cleavage rate=Number of cleavage/Number of zygotes
Number of available embryos
Total number of embryos transferred and frozen
Rate of available embryos
Rate of available embryos=Number of available embryos/Total number of embryos
Number of high-quality embryos
According to the Istanbul consensus workshop on embryo assessment
Rate of high-quality embryos
Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos
Implantation rate
Implantation rate=Number of gestational sacs/Number of embryos transferred
Miscarriage rate
Miscarriage rate=Number of miscarriage cycles/Number of clinical pregnancy cycles
The birth weight of the newborn
By checking medical records and telephone calls
The birth height of the newborn
By checking medical records and telephone calls
The congenital malformation rate of the newborn
By checking medical records and telephone calls

Full Information

First Posted
August 5, 2018
Last Updated
January 30, 2019
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03703700
Brief Title
The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
IVF-ET, infertility, aged, women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1466 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zishen Yutai pill group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zishen Yutai Pill
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
the clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancy cycles / Total number of embryo transfer cycles
Time Frame
1 year
Title
Live birth rate
Description
Live birth rate=Number of live birth cycles / Total number of embryo transfer cycles
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Serum E2 (Estradiol) concentrations on hCG (human chorionic gonadotrophin) injection day
Description
On the day of hCG injection
Time Frame
1 year
Title
Number of retrieved oocytes and zygotes
Description
By medical records
Time Frame
1 year
Title
Rate of retrieved oocytes
Description
Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles whose diameter ≥10mm on HCG injection day
Time Frame
1 year
Title
Number of cleavage
Description
Zygotes split into more than 2 cells
Time Frame
1 year
Title
Cleavage rate
Description
Cleavage rate=Number of cleavage/Number of zygotes
Time Frame
1 year
Title
Number of available embryos
Description
Total number of embryos transferred and frozen
Time Frame
1 year
Title
Rate of available embryos
Description
Rate of available embryos=Number of available embryos/Total number of embryos
Time Frame
1 year
Title
Number of high-quality embryos
Description
According to the Istanbul consensus workshop on embryo assessment
Time Frame
1 year
Title
Rate of high-quality embryos
Description
Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos
Time Frame
1 year
Title
Implantation rate
Description
Implantation rate=Number of gestational sacs/Number of embryos transferred
Time Frame
1 year
Title
Miscarriage rate
Description
Miscarriage rate=Number of miscarriage cycles/Number of clinical pregnancy cycles
Time Frame
1 year
Title
The birth weight of the newborn
Description
By checking medical records and telephone calls
Time Frame
1 year
Title
The birth height of the newborn
Description
By checking medical records and telephone calls
Time Frame
1 year
Title
The congenital malformation rate of the newborn
Description
By checking medical records and telephone calls
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertile women aged ≥35 and ≤42 years; intend to undergo IVF-ET (long or antagonist 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongzi Yang, professor
Phone
+86-020-81332233
Email
yangdz@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Li, professor
Phone
+86-020-81332233
Email
liyuliyu0922@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongzi Yang, professor
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing Health Center For Women and Children
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuehong Zhang
Facility Name
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Li, professor
Phone
+86-020-81332233
Email
liyuliyu0922@163.com
First Name & Middle Initial & Last Name & Degree
Dongzi Yang, professor
Phone
+86-020-81332233
Email
yangdz@mail.sysu.edu.cn
Facility Name
Liuzhou Maternal and Child Healthcare Hospital
City
Liuzhou
State/Province
Guangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinlin Li
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Third Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Reproductive and Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Gong
Facility Name
Northwest Women and Children's Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juanzi Shi
Facility Name
Tangdu Hospital of Air Force Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohong Wang
Facility Name
West China Second University Hospital/West China Women's and Children's Hospital
City
Sichuan
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shan Luo

12. IPD Sharing Statement

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

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