RCT Study on the Effect of ETN on Live Birth Rate in DOR Patients Undergoing IVF-ET

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

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.