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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, 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 for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile electro-thumbtack needle (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY). The patients were receive a treatment of 2 menstrual cycles
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints, 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 sham thumbtack needle for single use (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM2-6YDL), and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile sham electro-thumbtack needle (Hangzhou Zhuomai Medical Technology Co., LTD., model: ZM3-ZY). The patients were receive a treatment of 2 menstrual cycles
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGEvaluating the change of serum AMH level
Assessing patients' serum level of AMH in ng/ml at baseline and immediately after treatment on the second day of menstruation.
Time frame: 0 week and up to 4 weeks
Evaluating the change of the ovarian antral follicle count (AFC)
Counting the number of ovarian antral follicle count (AFC) on the second day of menstruation at baseline and immediately after treatment.
Time frame: 0 week and up to 4 weeks
Evaluating the serum levels of sex hormones
Evaluating the serum levels of sex hormones on the second day of menstruation at baseline and immediately after treatment
Time frame: 0 week and up to 4 weeks
Observing the sex hormones in follicular fluid collected from patients undergoing IVF/ICSI-ET cycle after treatment
Observing follicular fluid levels of sex hormones when patients undergoing IVF/ICSI -ET after the treatment.
Time frame: through study completion, an average of 1 year
Observing the level of transforming growth factor β (TGF β) in follicular fluid
Observing follicular fluid level of transforming growth factor β (TGF β) when patients undergoing IVF/ICSI -ET after the treatment.
Time frame: through study completion, an average of 1 year
Observing the level of tumor necrosis factor-α (TNF-α) in follicular fluid
Observing follicular fluid level of TNF-α when patients undergoing IVF/ICSI -ET after the treatment.
Time frame: through study completion, an average of 1 year
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Observing the level of reactive oxygen species (ROS) in follicular fluid
Observing follicular fluid level of ROS when patients undergoing IVF/ICSI -ET after the treatment.
Time frame: through study completion, an average of 1 year
Observing the level of superoxide dismutase (SOD) in follicular fluid
Observing follicular fluid level of SOD when patients undergoing IVF/ICSI -ET after the treatment.
Time frame: through study completion, an average of 1 year
Observing the ovum morphology (MII ovum ratio) during IVF-ET after treatment
Observing the MII ovum ratio during IVF-ET after treatment
Time frame: through study completion, an average of 1 year
Observing the embryo status
Observing the grade I embryo ratio, blastocyst formation rate and high quality blastocyst ratio when patients undergoing IVF/ICSI-ET after the treatment
Time frame: through study completion, an average of 1 year
Observing the pregnancy status
Observing the biochemical, clinical and ongoing pregnancy rate
Time frame: through study completion, an average of 1 year
Blood corticotropin-releasing hormone (CRH) examination
Observing the level of blood corticotropin-releasing hormone (CRH) at baseline and immediately after treatment
Time frame: 0 week and up to 12 weeks
Blood norepinephrine index examination
Observing the level of blood norepinephrine at baseline and immediately after treatment
Time frame: 0 week and up to 12 weeks
Blood 5-hydroxytryptamine (5-HT) index examination
Observing the level of blood 5-hydroxytryptamine (5-HT) at baseline and immediately after treatment
Time frame: 0 week and up to 12 weeks
Blood beta-aminobutyric acidne (DA) examination
Observing the level of blood beta-aminobutyric acidne (DA) at baseline and immediately after treatment
Time frame: 0 week and up to 12 weeks
Blood beta-aminobutyric acid (GABA) examination
Observing the level of blood beta-aminobutyric acid (GABA) at baseline and immediately after treatment
Time frame: 0 week and up to 12 weeks
Blood dopamine (DA) examination
Observing the level of blood dopamine (DA) at baseline and immediately after treatment
Time frame: 0 week and up to 12 weeks
Blood neuro-endorphin (β-ET) examination
Observing the level of blood neuro-endorphin (β-ET) at baseline and immediately after treatment
Time frame: 0 week and up to 12 weeks
Evaluation of anxiety status
Anxiety status will be assessed using Zung anxiety self-rating scale (Zung-SAS) at baseline and immediately after treatment.
Time frame: 0 week and up to 4 weeks
Evaluation of depression status
Depression status will be assessed using Zung depression self-rating scale (Zung-SDS) at baseline and immediately after treatment.
Time frame: 0 week and up to 4 weeks
Evaluation of quality of life
Quality of life will be assessed by SF-36 at baseline and immediately after treatment..
Time frame: 0 week and up to 4 weeks
Evaluation of sleep state
Sleep status will be evaluated using Pittsburgh sleep quality index (PSQI) at baseline and immediately after treatment.
Time frame: 0 week and up to 4 weeks