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NCT Number: NCT07769684

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

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.

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Key information

Conditions

Diminished Ovarian Reserve (DOR) Genital Diseases Infertility Infertility (IVF Patients) Urogenital Diseases

Age range

20 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shiyan People's Hospital, Shiyan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

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

Device

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.

Primary outcomes

  1. Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion

    Time frame: At birth

Secondary outcomes

  1. Clinical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion

    Time frame: About 28 days after embryo transfer

  2. Biochemical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion

    Time frame: About 14 days after embryo transfer

  3. The rate of miscarriage in pregnant patients who underwent their first embryo transfer in IVF-ET after the completion of treatment

    Time frame: During the whole period of pregnancy, assessed up to 40 weeks

  4. The rate of threatened miscarriage in pregnant patients who underwent their first embryo transfer in the first IVF-ET after treatment completion

    Time frame: During the whole period of pregnancy, assessed up to 40 weeks

  5. Pregnancy complications in patients who underwent their first embryo transfer in IVF-ET after the completion of treatment

    Time frame: During the whole period of pregnancy, assessed up to 40 weeks

  6. Serum level of six sex hormones

    Time frame: At baseline, and one month after the treatment

  7. Antral follicle count (AFC) in both ovaries

    Time frame: At baseline, and one month after the treatment

  8. Serum level of Anti-Müllerian Hormone (AMH)

    Time frame: At baseline, and one month after the treatment

  9. Number of oocytes and MII oocyte ratio retrieved on the first IVF-ET after treatment

    Time frame: On the day of oocyte retrieval during IVF-ET

  10. Embryo status in the first IVF-ET after treatment

    Time frame: One week after oocyte retrieval during the IVF-ET

  11. Depression assessment using the Zung Depression Self-Rating Scale (Zung-SDS)

    Time frame: At baseline, and one week after the treatment

  12. Anxiety assessment using the Zung Anxiety Self-Rating Scale (Zung-SAS)

    Time frame: At baseline, and one week after the treatment

  13. Assessment of quality of life (QOL) using MOS 36-Item Short Form Health Survey (SF-36)

    Time frame: At baseline, and one week after the treatment

  14. Sleep quality survey using Pittsburgh Sleep Quality Index (PSQI)

    Time frame: At baseline, and one week after the treatment

  15. Untargeted metabolomics analysis of blood

    Time frame: At baseline, and one month after the treatment

  16. Detection of cytokines in follicular fluid collected during the first IVF-ET after treatment

    Time frame: On the day of oocyte retrieval during IVF-ET

  17. Proteomic analysis of granulosa cells collected from the first IVF-ET after treatment

    Time frame: On the day of oocyte retrieval during IVF-ET

  18. Untargeted metabolomics analysis of follicular fluid collected from the first IVF-ET after treatment

    Time frame: On the day of oocyte retrieval during IVF-ET

  19. 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

    Time frame: 42 days after live birth

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Huang, Doctor

CONTACT

[email protected]

+86 27 83663275

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study 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

Acronym: ETN-LBR-DOR

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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