Poor ovarian response
Conditions
Interventions
Test group:Zishen Yutai Pills+Standard antagonist regimen
control group:Standard antagonist regimen
Sponsors
Hubei Provincial Maternal and Child Health Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 49 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily participate in this clinical trial and sign a written informed consent form; (2) Women with regular menstrual cycles, where the cycle length is between 21 and 35 days ; (3) Meet the criteria for POSEIDON subgroups 1 and 2 (low ovarian response): AFC = 5, AMH = 1.2 ng/mL, but with unexpectedly poor or suboptimal ovarian response; (4) Intending to undergo IVF/ICSI-ET (standard antagonist protocol)
Exclusion criteria
Exclusion criteria: (1) Recurrent implantation failure(patients who have experienced =3 failed transfers, or a cumulative total of 4–6 or more high-grade cleavage-stage embryos transferred, or =3 high-grade blastocysts transferred, all of which failed) (2) Untreated hydrosalpinx, or unresolved endometrial conditions (such as endometritis, endometrial polyps, or intrauterine adhesions); (3)Donor oocyte recipient cycles or in vitro maturation (IVM) cycles, or blastocyst biopsy for preimplantation genetic diagnosis (PGD) or preimplantation genetic testing for aneuploidies (PGT-A); (4) Suffering from a medical condition that makes them unsuitable for assisted reproductive technology at this time or unsuitable for pregnancy at this time (5) BMI = 28 kg/m² (6)Abnormal liver or kidney function (greater than 1.5 times the upper limit of normal) (7)Those who do not plan to undergo embryo transfer within the next six months (8)Those allergic to any component of the study drug; (9)Those who have received Chinese or Western medications to treat ovarian hyporesponsiveness within 1 month prior to randomization (such as growth hormone, DHEA, and other adjunctive medications, as well as traditional Chinese patent medicines like Menstrual Regulation and Fertility Pills, Kuntai Capsules, Dingkundan, Qilin Pills, Jinfeng Pills, and Gushen Antai Pills, and decoctions containing Cuscuta, Dipsacus, Phellodendron, and donkey-hide gelatin that tonify the kidneys and strengthen the spleen); (10) Participation in other clinical trials within 1 month prior to randomization; (11) Suspected or confirmed alcohol or substance abuse; (12) A history of smoking more than 10 cigarettes per day within 3 months prior to randomization; (13) Patients deemed unsuitable for this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Gn;Number of Gn days;Basal hormone levels;AMH;AFC;Daily serum E2 levels on HCG;HCG and Endometrial Thickness;Number of cycles/rate;Mature Oocyte Rate (MII Oocyte Rate);Number of fertilized 2PN cells;Number of high-quality embryos / High-quality embryo rate;Fresh Cycle Transplant Survival Rate;Biochemical pregnancy rate in fresh-cycle embryo transfer;Clinical pregnancy rate following fresh-cycle embryo transfer;Live birth rate following fresh-cycle embryo transfer;Cumulative cycle implantation rate;Cumulative biochemical pregnancy rate per cycle;Cumulative clinical pregnancy rate;Cumulative live birth rate;Miscarriage rate; | — |
Countries
China
Contacts
Public ContactJie Zheng
Hubei Provincial Maternal and Child Health Hospital
Outcome results
None listed