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NCT07769684

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

Sponsor: Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

20 Years - 42 Years

Study Type

INTERVENTIONAL

Enrollment

406

Start Date

2026-08-01

Completion Date

2031-12-31

Last Updated

2026-08-18

Healthy Volunteers

Conditions

Diminished Ovarian Reserve (DOR)Infertility (IVF Patients)

Interventions

DEVICE

electro-thumbtack needle (ETN) / thumbtack needle (TN)

The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints (3 cun below the umbilicus and 3 cun lateral to the anterior midline), bilateral spleen (SP) 6, bilateral stomach (ST) 36, bilateral bladder (BL) 23 and bilateral EX-B7 will be used. Eight points of CV4, CV3, SP6, ST36 and BL23 were treated by the sterile thumbtack needle (TN) for single use , and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile electro-thumbtack needle (ETN). Electrode pads are attached on the ETN and connected to the electroacupuncture apparatus. Medium-intensity stimulation is applied for 15 minutes. After stimulation, the electroacupuncture apparatus and electrode pads are removed, but the ETN remain in place for 5 - 7 days. During the needle retention period, the abdominal ovary acupoints and the back EX-B7 are stimulated alternately every day for 15 minutes each time using the electroacupuncture apparatus device.

DEVICE

Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)

The control group was selected with the same acupoints as the treatment group. The practitioner disinfected both hands and strictly sterilized the local skin of the acupoints, then attached sham ETN and sham TN to the surface of the acupoints. The stimulation methods and frequencies of sham ETN and sham TN were identical to those used in the treatment group.

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.

Locations (4)

Shiyan People's Hospital

Shiyan, Hubei, China

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine