The Application of Zishen Yutai Pill in Aged Women Undergoing in Vitro Fertilization-embryo Transfer: a Multi-center Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,467
- 试验地点
- 12
- 主要终点
- Live Birth Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Zishen Yutai Pill (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Live Birth Rate
时间窗: 1 year after embryo transfer day, up to a maximum duration of 58 weeks
Live birth rate=Number of live birth / Paticipants randomized
次要结局
- 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)
- Preterm Delivery Among Live Birth(1 year after embryo transfer, up to 58 weeks)
- Cleavage Rate(On embryo transfer day, approximately 6 weeks)
- Number of Available Embryos(On embryo transfer day, approximately 6 weeks)
- Rate of Available Embryos(On embryo transfer day, approximately 6 weeks)
- Number of High-quality Embryos(On embryo transfer day, approximately 6 weeks)
- Rate of High-quality Embryos(On embryo transfer day, approximately 6 weeks)
- Biochemical Pregnancy Rate(14 days after ET day, approximately 8 weeks)
- Implantation Rate(five weeks after ET day, approximately 11 weeks)
- Clinical Pregnancy Rate(five weeks after ET day, approximately 11 weeks)
- Miscarriage Rate (Among Positive Pregnancy Test Population)(1 year after embryo transfer, up to 58 weeks)
- Miscarriage Rate (Among Clinical Pregnancy Population)(1 year after embryo transfer, up to 58 weeks)
- The Birth Weight of the Newborn(1 year after embryo transfer, up to 58 weeks)
- The Birth Height of the Newborn(1 year after embryo transfer, up to 58 weeks)
- Low Birth Weight Among Neonates(1 year after embryo transfer, up to 58 weeks)
- Congenital Anomalies Among Neonates(1 year after embryo transfer, up to 58 weeks)
- Neonates Entering NICU(1 year after embryo transfer, up to 58 weeks)
研究者
Dongzi Yang
professor，Chief Physician，doctoral supervisor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University