Clinical trial NCT03703700: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: IVF-ET
infertility
aged
women
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 1467
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Live Birth Rate
timeFrame: 1 year after embryo transfer day, up to a maximum duration of 58 weeks
Secondary outcomes:
measure: Number of Retrieved Oocytes
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Rate of Retrieved Oocytes
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Number of Matured Oocytes Retrieved
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Rate of Matured Oocytes
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Number of Cleavage
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Cleavage Rate
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Number of Available Embryos
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Rate of Available Embryos
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Number of High-quality Embryos
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Rate of High-quality Embryos
timeFrame: On embryo transfer day, approximately 6 weeks
measure: Biochemical Pregnancy Rate
timeFrame: 14 days after ET day, approximately 8 weeks
measure: Implantation Rate
timeFrame: five weeks after ET day, approximately 11 weeks
measure: Clinical Pregnancy Rate
timeFrame: five weeks after ET day, approximately 11 weeks
measure: Miscarriage Rate (Among Positive Pregnancy Test Population)
timeFrame: 1 year after embryo transfer, up to 58 weeks
measure: Miscarriage Rate (Among Clinical Pregnancy Population)
timeFrame: 1 year after embryo transfer, up to 58 weeks
measure: The Birth Weight of the Newborn
timeFrame: 1 year after embryo transfer, up to 58 weeks
measure: The Birth Height of the Newborn
timeFrame: 1 year after embryo transfer, up to 58 weeks
measure: Preterm Delivery Among Live Birth
timeFrame: 1 year after embryo transfer, up to 58 weeks
measure: Low Birth Weight Among Neonates
timeFrame: 1 year after embryo transfer, up to 58 weeks
measure: Congenital Anomalies Among Neonates
timeFrame: 1 year after embryo transfer, up to 58 weeks
measure: Neonates Entering NICU
timeFrame: 1 year after embryo transfer, up to 58 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Health Center For Women and Children
state: Chongqing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou Maternal and Child Healthcare Hospital
state: Guangxi
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Reproductive and Genetic Hospital of CITIC-XIANGYA
state: Hunan
city: Suzhou
country: China
facility: The Affiliated Suzhou Hospital of Nanjing Medical University
state: Jiangsu
city: Jinan
country: China
facility: Reproductive Hospital affiliated to Shandong University
state: Shandong
city: Xi'an
country: China
facility: Northwest Women and Children's Hospital
state: Shanxi
city: Xi'an
country: China
facility: Tangdu Hospital of Air Force Medical University
state: Shanxi
city: Sichuan
country: China
facility: West China Second University Hospital/West China Women's and Children's Hospital
state: Sichuan
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Dongzi Yang, professor
role: PRINCIPAL_INVESTIGATOR
References: