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

Diminished Ovarian Reserve Clinical Trial

Official title:

Effect of Thumbtack Needle on Ovarian Function of Women With Diminished Ovarian Reserve (DOR): A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277948
• Other study ID #: Effect of TTN on DOR
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 31, 2026

Study information

• Verified date: March 2022
• Source: Huazhong University of Science and Technology
• Contact: Dongmei Huang
• Phone: 86-27-83663275
• Email: hdmjcr[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diminished Ovarian Reserve

Intervention

Other:
• active thumbtack needle
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
• sham thumbtack needle
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

Locations

Country	Name	City	State
China	Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating 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.	0 week and up to 4 weeks
Primary	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.	0 week and up to 4 weeks
Secondary	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	0 week and up to 4 weeks
Secondary	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.	through study completion, an average of 1 year
Secondary	Observing the level of transforming growth factor ß (TGF ß) in follicular fluid	Observing follicular fluid level of transforming growth factor ß (TGF ß) when patients undergoing IVF/ICSI; -ET after the treatment.	through study completion, an average of 1 year
Secondary	Observing the level of tumor necrosis factor-a (TNF-a) in follicular fluid	Observing follicular fluid level of TNF-a when patients undergoing IVF/ICSI; -ET after the treatment.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	Observing the ovum morphology (MII ovum ratio) during IVF-ET after treatment	Observing the MII ovum ratio during IVF-ET after treatment	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	Observing the pregnancy status	Observing the biochemical, clinical and ongoing pregnancy rate	through study completion, an average of 1 year
Secondary	Blood corticotropin-releasing hormone (CRH) examination	Observing the level of blood corticotropin-releasing hormone (CRH) at baseline and immediately after treatment	0 week and up to 12 weeks
Secondary	Blood norepinephrine index examination	Observing the level of blood norepinephrine at baseline and immediately after treatment	0 week and up to 12 weeks
Secondary	Blood 5-hydroxytryptamine (5-HT) index examination	Observing the level of blood 5-hydroxytryptamine (5-HT) at baseline and immediately after treatment	0 week and up to 12 weeks
Secondary	Blood beta-aminobutyric acidne (DA) examination	Observing the level of blood beta-aminobutyric acidne (DA) at baseline and immediately after treatment	0 week and up to 12 weeks
Secondary	Blood beta-aminobutyric acid (GABA) examination	Observing the level of blood beta-aminobutyric acid (GABA) at baseline and immediately after treatment	0 week and up to 12 weeks
Secondary	Blood dopamine (DA) examination	Observing the level of blood dopamine (DA) at baseline and immediately after treatment	0 week and up to 12 weeks
Secondary	Blood neuro-endorphin (ß-ET) examination	Observing the level of blood neuro-endorphin (ß-ET) at baseline and immediately after treatment	0 week and up to 12 weeks
Secondary	Evaluation of anxiety status	Anxiety status will be assessed using Zung anxiety self-rating scale (Zung-SAS) at baseline and immediately after treatment.	0 week and up to 4 weeks
Secondary	Evaluation of depression status	Depression status will be assessed using Zung depression self-rating scale (Zung-SDS) at baseline and immediately after treatment.	0 week and up to 4 weeks
Secondary	Evaluation of quality of life	Quality of life will be assessed by SF-36 at baseline and immediately after treatment..	0 week and up to 4 weeks
Secondary	Evaluation of sleep state	Sleep status will be evaluated using Pittsburgh sleep quality index (PSQI) at baseline and immediately after treatment.	0 week and up to 4 weeks