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

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ClinicalTrials.gov Identifier: NCT03703700
Recruitment Status : Unknown
Verified January 2019 by Dongzi Yang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Recruitment status was:  Not yet recruiting
First Posted : October 12, 2018
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Dongzi Yang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Zishen Yutai Pill Drug: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 1 year ]
    the clinical pregnancy determined by the ultrasound, and Clinical pregnancy rate=Number of clinical pregnancy cycles / Total number of embryo transfer cycles

  2. Live birth rate [ Time Frame: through study completion, an average of 1 year ]
    Live birth rate=Number of live birth cycles / Total number of embryo transfer cycles


Secondary Outcome Measures :
  1. Serum E2 (Estradiol) concentrations on hCG (human chorionic gonadotrophin) injection day [ Time Frame: 1 year ]
    On the day of hCG injection

  2. Number of retrieved oocytes and zygotes [ Time Frame: 1 year ]
    By medical records

  3. Rate of retrieved oocytes [ Time Frame: 1 year ]
    Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles whose diameter ≥10mm on HCG injection day

  4. Number of cleavage [ Time Frame: 1 year ]
    Zygotes split into more than 2 cells

  5. Cleavage rate [ Time Frame: 1 year ]
    Cleavage rate=Number of cleavage/Number of zygotes

  6. Number of available embryos [ Time Frame: 1 year ]
    Total number of embryos transferred and frozen

  7. Rate of available embryos [ Time Frame: 1 year ]
    Rate of available embryos=Number of available embryos/Total number of embryos

  8. Number of high-quality embryos [ Time Frame: 1 year ]
    According to the Istanbul consensus workshop on embryo assessment

  9. Rate of high-quality embryos [ Time Frame: 1 year ]
    Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos

  10. Implantation rate [ Time Frame: 1 year ]
    Implantation rate=Number of gestational sacs/Number of embryos transferred

  11. Miscarriage rate [ Time Frame: 1 year ]
    Miscarriage rate=Number of miscarriage cycles/Number of clinical pregnancy cycles

  12. The birth weight of the newborn [ Time Frame: 1 year ]
    By checking medical records and telephone calls

  13. The birth height of the newborn [ Time Frame: 1 year ]
    By checking medical records and telephone calls

  14. The congenital malformation rate of the newborn [ Time Frame: 1 year ]
    By checking medical records and telephone calls


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703700


Contacts
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Contact: Dongzi Yang, professor +86-020-81332233 yangdz@mail.sysu.edu.cn
Contact: Yu Li, professor +86-020-81332233 liyuliyu0922@163.com

Locations
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China, Chongqing
Chongqing Health Center For Women and Children
Chongqing, Chongqing, China
China, Gansu
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Contact: Xuehong Zhang         
China, Guangdong
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Contact: Yu Li, professor    +86-020-81332233    liyuliyu0922@163.com   
Contact: Dongzi Yang, professor    +86-020-81332233    yangdz@mail.sysu.edu.cn   
China, Guangxi
Liuzhou Maternal and Child Healthcare Hospital
Liuzhou, Guangxi, China
Contact: Xinlin Li         
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
China, Hunan
Reproductive and Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China, 410000
Contact: Fei Gong         
China, Shanxi
Northwest Women and Children's Hospital
Xi'an, Shanxi, China
Contact: Juanzi Shi         
Tangdu Hospital of Air Force Medical University
Xi'an, Shanxi, China
Contact: Xiaohong Wang         
China, Sichuan
West China Second University Hospital/West China Women's and Children's Hospital
Sichuan, Sichuan, China
Contact: Shan Luo         
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Dongzi Yang, professor Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Responsible Party: Dongzi Yang, professor，Chief Physician，doctoral supervisor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03703700    
Other Study ID Numbers: 2018112704
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dongzi Yang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University:
IVF-ET
infertility
aged
women
Additional relevant MeSH terms:
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Infertility
Infertility, Female