ITMCTR2026001651进行中（未招募）Unknown
A Randomized, Controlled Clinical Study on the Use of Zishen Yutai Pills in In Vitro Fertilization and Embryo Transfer for Patients with Unexpected Ovarian Hyporesponsiveness
Hubei Provincial Maternal and Child Health Hospital0 个研究点开始时间: 2026年8月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 至 49（—）
- 性别
- Female
入选标准
- •(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)
排除标准
- •(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
研究者
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