poor ovarian response
Conditions
Interventions
treatment group:Zishen Yutai Pills
Placebo group:Placebo
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participated in this clinical trial and signed written informed consent; 2. Those with regular menstrual cycles, 21 = 35 years with depressed ovarian reserve (AFC < 5, AMH <1.2 ng/mL); 4. Meets the criteria for the diagnosis of deficiency of both spleen and kidney in Chinese medicine; 5. Patient who plan to perform IVF/ICSI-ET (standard antagonist protocol).
Exclusion criteria
Exclusion criteria: 1. Repeated implantation failure (those who have experienced >= 3 transfers or a cumulative number of transfers of 4-6 or more embryos at the high-scoring oocyte stage or >= 3 high-scoring blastocysts have failed); 2. Untreated hydrosalpinx, untreated endometrial disease (e.g., endometritis, endometrial polyps, intrauterine adhesions), etc. 3. Having a medical condition that is not suitable for current assisted reproductive technology or for pregnancy; 4. BMI >=28 kg/m2.; 5. Those with abnormal liver or kidney function (greater than 1.5 of the upper limit of normal); 6. Patients whose husbands have very severe oligospermia; 7. Those who do not intend to transplant within six months; 8. Those who are allergic to the components of the study drug; 9. Those who have received Chinese or Western medicines for the treatment of poor ovarian response within 1 month prior to randomization (e.g., adjuvant medicines such as growth hormone, DHEA, and traditional Chinese medicines. Traditional Chinese medicines include patent TCM drugs, like Tiaojing Chuyun pills, Kuntai capsules, Dingkundan, Qilin pills, Jinfeng pills, Gushen Antai pills, etc., or decotion containing Cuscutae Semen, Asini Corii Colla, Taxilli Herba, Dipsaci Radix and other herbal medicine with effects of tonifying kidney and spleen); 10. Patients who have participated in other clinical trials within 1 month prior to randomization; 11. Suspected or confirmed alcohol or drug abusers; 12. Have a smoking habit of more than 10 cigarettes per day within 3 months prior to randomization; 13. Those who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of high-quality embryos;High quality embryo rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gonadotropin (Gn) total dose used;Number of days of use of Gn;Basic Sex Hormone;anti-Müllerian hormone;Antral follicle count;Serum estradiol levels on HCG day;Endometrial thickness on HCG day;Number/rate of cancellation cycles;Number of oocytes retrieved;Number of 2 pronuclei (PN) fertilizations;Implantation rate by fresh cycle transplant;Clinical pregnancy rate by fresh-cycle transfer;Live Birth Rate by Fresh Cycle Transplantation;Rate of pregnancy loss in first trimester ;implantation rate of Cumulative cycle transplant;Cumulative pregnancy rate;Cumulative live birth rate;Adverse reactions/adverse events;Vital signs;Routine blood, urine tests and blood biochemical tests;complication; | — |
Countries
China
Contacts
Public ContactDong Li
Peking University Third Hospital
Outcome results
None listed