The effect of Zishen Yutai pills on the improvement of IVF oocyte utilization rate in POI patients: a prospective multicenter randomized controlled trial
- Conditions
- premature ovarian insufficiency
- Registration Number
- ITMCTR2000003200
- Lead Sponsor
- Reproductive Medical Center of Ruijin Hospital School of Medicine, Shanghai Jiaotong University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
1. Volunteer to participate in this study, be willing to use medication according to the treatment plan and follow up, and sign the informed consent;
2. The patient was in good health, and there were no obvious abnormalities in clinical physical examination and laboratory examination (except for POI related indicators);
3. Aged between 20 and 40 years; Conforming to the preliminary screening conditions of POI (Poseidon Group 3 and Group 4) as ovarian basal sinus follicles less than 5; AMH <1.2ng/ml;
4. Hysteroscopy or fallopian tube examination: the uterine cavity shape is normal; normal uterine cavity shape after the operation drugs and the like;
5. The karyotype of the couple is normal and there is no genetic disease.
1. Patients with severe diseases of the respiratory system or endocrine system or nervous system or cardiovascular system or diseases of the digestive system or genitourinary system or family history of hereditary diseases;
2. Who has suffered from or is suffering from contraindications of Zishen Yutai pills or alleric to Zishen Yutai pills;
3. Smoking more than 20 cigarettes a day;
4. Patients with genital tract virus infection and cervical laxity; With reproductive organ malformation or chromosome abnormality;
5. Patients with HBV, HCV, HIV or severe autoimmune diseases or tumors or cancers;
6. Patients with endometrial lesions.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oocyte utilization rate;
- Secondary Outcome Measures
Name Time Method implantation rate (number of pregnant cases which are confirmed by blood ß-hCG examination / number of transplanted cases);Adverse reaction rate;high qualified embryo rate;number of retrieved oocytes;premature birth rate (number of premature births/ number of pregnant cases confirmed by ultrasound);early miscarriage rate (number of miscarriage cases / number of pregnant cases confirmed by ultrasound);multiple pregnancy rate (Number of twins and above cases/number of pregnant cases which are confirmed by ultrasound);Clinical pregnancy rate (Clinical pregnancies/total number of embryo transfer cycles);fertilization rate (number of fertilized oocytes / number of retrieved oocytes);Effective embryo rate;Cancellation rate;live birth rate (number of deliveries / number of transplantation cycles);cleavage rate;late miscarriage rate (number of miscarriage cases / number of pregnant cases confirmed by ultrasound);