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

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03703700
• Other study ID #: 2018112704
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Dongzi Yang, professor
• Phone: +86-020-81332233
• Email: yangdz[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1466
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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
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.

Locations

Country	Name	City	State
China	Reproductive and Genetic Hospital of CITIC-XIANGYA	Changsha	Hunan
China	Chongqing Health Center For Women and Children	Chongqing	Chongqing
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Liuzhou Maternal and Child Healthcare Hospital	Liuzhou	Guangxi
China	West China Second University Hospital/West China Women's and Children's Hospital	Sichuan	Sichuan
China	Northwest Women and Children's Hospital	Xi'an	Shanxi
China	Tangdu Hospital of Air Force Medical University	Xi'an	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The Third Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	Live birth rate	Live birth rate=Number of live birth cycles / Total number of embryo transfer cycles	through study completion, an average of 1 year
Secondary	Serum E2 (Estradiol) concentrations on hCG (human chorionic gonadotrophin) injection day	On the day of hCG injection	1 year
Secondary	Number of retrieved oocytes and zygotes	By medical records	1 year
Secondary	Rate of retrieved oocytes	Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles whose diameter =10mm on HCG injection day	1 year
Secondary	Number of cleavage	Zygotes split into more than 2 cells	1 year
Secondary	Cleavage rate	Cleavage rate=Number of cleavage/Number of zygotes	1 year
Secondary	Number of available embryos	Total number of embryos transferred and frozen	1 year
Secondary	Rate of available embryos	Rate of available embryos=Number of available embryos/Total number of embryos	1 year
Secondary	Number of high-quality embryos	According to the Istanbul consensus workshop on embryo assessment	1 year
Secondary	Rate of high-quality embryos	Rate of high-quality embryos=Number of high-quality embryos/Number of available embryos	1 year
Secondary	Implantation rate	Implantation rate=Number of gestational sacs/Number of embryos transferred	1 year
Secondary	Miscarriage rate	Miscarriage rate=Number of miscarriage cycles/Number of clinical pregnancy cycles	1 year
Secondary	The birth weight of the newborn	By checking medical records and telephone calls	1 year
Secondary	The birth height of the newborn	By checking medical records and telephone calls	1 year
Secondary	The congenital malformation rate of the newborn	By checking medical records and telephone calls	1 year