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Not yet recruiting NCT07142187

The Clinical Trial of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR)

No phase Interventional Diminished Ovarian Reserve (DOR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: electro-thumbtack needle, placebo electro-thumbtack needle.
Who it may be relevant to
Registry conditions: Diminished Ovarian Reserve (DOR). Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR): a Multicenter Randomized Controlled Clinical Trial

Overview

This study will include 246 patients with ovarian reserve dysfunction (DOR), who will be randomly divided into a treatment group and a control group, with 123 patients in each group. The treatment group will receive electro-thumbtack needle treatment, while the control group will receive placebo electro-thumbtack needle treatment. Both groups will receive a treatment course of 3 menstrual cycles. This study evaluates the effect of electrocautery on the live birth rate of patients with DOR.

Interventions

  • Other electro-thumbtack needle
    The treatment acupoints include bilateral ovarian acupoints, Guan Yuan (CV4), bilateral Shen Shu (BL23), bilateral waist and eye acupoints (EX-B7), bilateral San Yin Jiao (SP6), and bilateral Zu San Li (ST36), totaling 11 acupoints. Among them, the bilateral ovarian acupoints and bilateral waist eye acupoints (EX-B7) were treated with electro-thumbtack needle. Other acupoints were treated with thumbtack needle.Choose a sparse and dense waveform, adjust the intensity to the maximum patient can to
  • Other placebo electro-thumbtack needle
    The control group selected acupoints that were the same as the treatment group. Bilateral ovarian acupoints and bilateral waist and eye acupoints are treated with placebo electro-thumbtack needle, while other acupoints are treated with placebo electro-thumbtack needle. The treatment methods for placebo electro-thumbtack needle and placebo thumbtack needle are the same as those for the treatment group.

Primary outcome measures

  • live birth rate [Time frame: 3 months]
Secondary outcome measures (12)
  • Biochemical pregnancy rate [Time frame: 3 months]
  • clinical pregnancy rate [Time frame: 3 months]
  • Threatened miscarriage rate [Time frame: 3 months]
  • abortion rate [Time frame: 3 months]
  • Anti Mullerian hormone (AMH) [Time frame: 3 months]
  • Antral Follicle Count (AFC) [Time frame: 3 months]
  • follicle stimulating hormone（FSH） [Time frame: 3 months]
  • Luteinizing hormone (LH) [Time frame: 3 months]
  • estradiol（E2） [Time frame: 3 months]
  • Progesterone（P） [Time frame: 3 months]
  • Prolactin（PRL） [Time frame: 3 months]
  • Testosterone（T） [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • The age range is 18-40 years old;
  • Meets the diagnostic criteria for DOR as follows: ① AMH<1.1 ng/ml; ② 10 U/L < FSH < 25U/L or FSH/LH > 3.6; ③ The total number of follicles (AFC) in both basal sinuses is less than 7. If any two of the above criteria (①②③) are met, it can be diagnosed as DOR.
  • At least one side of the patient's fallopian tube is unobstructed;
  • The semen routine examination of the patient's spouse is normal;
  • Voluntarily sign the informed consent form.

Exclusion criteria

  • Chromosomal or genetic abnormalities in either the female or male partner;
  • Women with blocked fallopian tubes on both sides;
  • Have a history of ovarian surgery, such as ovarian teratoma or ovarian chocolate cyst surgery;
  • The female party suffers from uncorrected endocrine disorders such as simple hyperthyroidism or hypothyroidism, hyperprolactinemia, and pancreatic islet dysfunction;
  • Hormone resistance, diabetes, adrenal diseases, etc;
  • The woman has a clearly diagnosed autoimmune disease such as systemic lupus erythematosus, rheumatoid arthritis;
  • Antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis, etc;
  • The female or male partner has a history of malignant tumors and has received treatment with radiotherapy and chemotherapy;
  • The woman has received acupuncture and moxibustion or press acupuncture treatment in recent 3 months;
  • Those who take traditional Chinese medicine decoctions or granules during treatment;
  • Men with abnormal semen examination;
  • Clear diagnosis of moderate or severe adenomyosis;
  • Clearly diagnose uterine fibroids with a diameter greater than 5cm;
  • I do not agree to sign the informed consent form for this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07142187 · TJ-IRB202508011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗