NCT07769684尚未招募不适用
Effect of Electro-thumbtack Needle (ETN) on Live Birth Rate in Patients With Diminished Ovarian Reserve (DOR) Undergoing IVF-ET: A Multicenter Randomized Controlled Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 406
- 试验地点
- 4
- 主要终点
- Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion
研究概览
简要总结
The goal of this clinical trial is to examine the effect of ETN on live birth rate in patients with diminished ovarian reserve (DOR) undergoing in vitro fertilizitaion-embryo transfer (IVF-ET). Four hundred and six patients with DOR will be enrolled randomly divided into treatment group and control group, with 203 patients in each group. The treatment group will receive electro-thumbtack needle (ETN) therapy, while the control group received placebo ETN. Both groups initiated treatment 1 to 3 menstrual cycles before IVF-ET and continued until the intramuscular injection of HCG (night injection) during the IVF cycle. The study will observe and compare the pregnancy outcomes (including live birth rate, clinical pregnancy rate, biochemical pregnancy rate, threatened abortion, abortion, oocyte retrieval, and embryo quality), ovarian reserve function, anxiety, depression, sleep status, and quality of life between the two groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Age between 20-42 years old;
- •2. Meet the DOR diagnostic criteria: Diagnosis of diminished ovarian reserve (DOR) can be made if any two of the following three criteria are met: ①Serum AMH level ≤ 1.1 ng/mL; ②On days 2-4 of the menstrual cycle, transvaginal ultrasound demonstrates a total number of basal antral follicles (diameter 2-10 mm) in both ovaries <7 (antral follicle counting, AFC); ③For two consecutive menstrual cycles, on days 2-4, serum FSH levels range from 10 U/L to <25 U/L.
- •3. Semen routine examination of the participant's spouse is normal: sperm concentration ≥15×10⁶/mL, proportion of forward-moving sperm ≥32%, proportion of normally shaped sperm ≥4%;
- •4. Intend to undergo In Vitro Fertilization - Embryo Transfer (IVF-ET);
- •5. Voluntarily participate in this study, sign the informed consent form, and be able to cooperate to complete the treatment and follow-up.
排除标准
- •1. Chromosomal or genetic abnormalities in the female or male partner;
- •2. History of ovarian surgery, such as surgery for ovarian teratomas or ovarian chocolate cysts;
- •3. Uterine abnormalities that may affect embryo implantation (including uterine malformations, uterine tuberculosis, adenomyosis, and submucosal myomas >4 cm);
- •4. Unresolved intrauterine adhesions, endometritis, or endometrial polyps;
- •5. The female partner has uncorrected endocrine disorders such as uncomplicated hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, or has taken antipsychotic medications in the past 3 months;
- •6. The female partner has a confirmed diagnosis of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjögren's syndrome, or Hashimoto's thyroiditis;
- •7. Three or more failed embryo transfers;
- •8. History of malignant tumors in the female or male partner with prior radiotherapy or chemotherapy;
- •9. The female partner has received acupuncture or press needle therapy in the past 3 months;
- •10. Use of Chinese herbal decoctions or granules during treatment;
- •11. Abnormal semen analysis in the male partner;
- •12. Refusal to undergo in vitro fertilization - embryo transfer (IVF-ET);
- •13. Refusal to sign the informed consent form for this study.
结局指标
主要结局
Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion
时间窗: At birth
次要结局
- Number of oocytes and MII oocyte ratio retrieved on the first IVF-ET after treatment(On the day of oocyte retrieval during IVF-ET)
- Clinical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion(About 28 days after embryo transfer)
- Biochemical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion(About 14 days after embryo transfer)
- The rate of miscarriage in pregnant patients who underwent their first embryo transfer in IVF-ET after the completion of treatment(During the whole period of pregnancy, assessed up to 40 weeks)
- The rate of threatened miscarriage in pregnant patients who underwent their first embryo transfer in the first IVF-ET after treatment completion(During the whole period of pregnancy, assessed up to 40 weeks)
- Pregnancy complications in patients who underwent their first embryo transfer in IVF-ET after the completion of treatment(During the whole period of pregnancy, assessed up to 40 weeks)
- Serum level of six sex hormones(At baseline, and one month after the treatment)
- Antral follicle count (AFC) in both ovaries(At baseline, and one month after the treatment)
- Serum level of Anti-Müllerian Hormone (AMH)(At baseline, and one month after the treatment)
- Embryo status in the first IVF-ET after treatment(One week after oocyte retrieval during the IVF-ET)
- Depression assessment using the Zung Depression Self-Rating Scale (Zung-SDS)(At baseline, and one week after the treatment)
- Anxiety assessment using the Zung Anxiety Self-Rating Scale (Zung-SAS)(At baseline, and one week after the treatment)
- Assessment of quality of life (QOL) using MOS 36-Item Short Form Health Survey (SF-36)(At baseline, and one week after the treatment)
- Sleep quality survey using Pittsburgh Sleep Quality Index (PSQI)(At baseline, and one week after the treatment)
- Untargeted metabolomics analysis of blood(At baseline, and one month after the treatment)
- Detection of cytokines in follicular fluid collected during the first IVF-ET after treatment(On the day of oocyte retrieval during IVF-ET)
- Proteomic analysis of granulosa cells collected from the first IVF-ET after treatment(On the day of oocyte retrieval during IVF-ET)
- Untargeted metabolomics analysis of follicular fluid collected from the first IVF-ET after treatment(On the day of oocyte retrieval during IVF-ET)
- The health status of the offspring of the first embryo transfer in the first IVF-ET, including gestational age at birth, infant weight and height, presence of malformations, neonatal jaundice, hypoglycemia, etc(42 days after live birth)
研究者
Dongmei Huang
associate Professor
Huazhong University of Science and Technology
研究点 (4)
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