Clinical trial NCT05277948: Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR)
Official title: Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR): A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diminished Ovarian Reserve
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluating the change of serum AMH level
timeFrame: 0 week and up to 4 weeks
measure: Evaluating the change of the ovarian antral follicle count (AFC)
timeFrame: 0 week and up to 4 weeks
Secondary outcomes:
measure: Evaluating the serum levels of sex hormones
timeFrame: 0 week and up to 4 weeks
measure: Observing the sex hormones in follicular fluid collected from patients undergoing IVF/ICSI-ET cycle after treatment
timeFrame: through study completion, an average of 1 year
measure: Observing the level of transforming growth factor β (TGF β) in follicular fluid
timeFrame: through study completion, an average of 1 year
measure: Observing the level of tumor necrosis factor-α (TNF-α) in follicular fluid
timeFrame: through study completion, an average of 1 year
measure: Observing the level of reactive oxygen species (ROS) in follicular fluid
timeFrame: through study completion, an average of 1 year
measure: Observing the level of superoxide dismutase (SOD) in follicular fluid
timeFrame: through study completion, an average of 1 year
measure: Observing the ovum morphology (MII ovum ratio) during IVF-ET after treatment
timeFrame: through study completion, an average of 1 year
measure: Observing the embryo status
timeFrame: through study completion, an average of 1 year
measure: Observing the pregnancy status
timeFrame: through study completion, an average of 1 year
measure: Blood corticotropin-releasing hormone (CRH) examination
timeFrame: 0 week and up to 12 weeks
measure: Blood norepinephrine index examination
timeFrame: 0 week and up to 12 weeks
measure: Blood 5-hydroxytryptamine (5-HT) index examination
timeFrame: 0 week and up to 12 weeks
measure: Blood beta-aminobutyric acidne (DA) examination
timeFrame: 0 week and up to 12 weeks
measure: Blood beta-aminobutyric acid (GABA) examination
timeFrame: 0 week and up to 12 weeks
measure: Blood dopamine (DA) examination
timeFrame: 0 week and up to 12 weeks
measure: Blood neuro-endorphin (β-ET) examination
timeFrame: 0 week and up to 12 weeks
measure: Evaluation of anxiety status
timeFrame: 0 week and up to 4 weeks
measure: Evaluation of depression status
timeFrame: 0 week and up to 4 weeks
measure: Evaluation of quality of life
timeFrame: 0 week and up to 4 weeks
measure: Evaluation of sleep state
timeFrame: 0 week and up to 4 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science Tech
name: Hanwang Zhang
role: PRINCIPAL_INVESTIGATOR
References: