Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR)

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Diminished Ovarian Reserve

Treatments: Other: sham thumbtack needle; Other: active thumbtack needle

Study type: Interventional

Funder types: Other

Identifiers

NCT05277948

Effect of TTN on DOR

Details and patient eligibility

About

Using a multi-center, large sample, randomized, controlled and blind clinical trial to evaluate the effect of thumbtack needle on ovarian function of patients with diminished ovarian reserve (DOR).

Full description

Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. Thumbtack needle, as a kind of acupuncture, has been found effective in treating DOR in our clinic. In this trial, the investigators Using a multi-center, large sample, randomized, controlled and blind clinical trial to evaluate the effect of thumbtack needle on ovarian function of patients with diminished ovarian reserve (DOR).

First, patients will be recruited according to the inclusion criteria and exclusion criteria.

Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life, sleep status) will be taken.

Third, each patient will receive the treatment of thumbtack needle for a total of 2 menstrual cycles.

Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.

Enrollment: 240 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with age between 18 and 40 years;
• Low ovarian reserve: AMH<1.1ng/ml; or AFC<7; or 10 U/L<FSH<25U/L or FSH/LH>3.6; or has a history of poor ovarian response, that is, in the last controlled hyperstimulation cycle, the number of retrieved oocytes<3. Any 2 of the above 4 conditions are met.
• Sign informed consent voluntarily.

Exclusion criteria

• Patient's chromosome is abnormal.
• Patients with previous ovarian surgery because of such as ovarian teratoma or chocolate cyst and so on.
• Patients with uncorrected endocrine disease, such as: Simple hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
• Patients with definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjogren's syndrome, Hashimoto's thyroiditis.
• Patients with a history of cancer and has received radiotherapy or chemotherapy.
• Patients had the treatment of acupuncture or thumbtack needle in recent 3 months.
• Patients who take Chinese medicine decoction or granule during the treatment;
• Patients unwilling to sign the informed consent of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

treatment group

Active Comparator group

Description:

Active thumbtack needle will be used for the treatment group

Treatment:

Other: active thumbtack needle

control group

Sham Comparator group

Description:

Sham thumbtack needle will be used for the control group

Treatment:

Other: sham thumbtack needle