An interventional study of electro-thumbtack needle (ETN) / thumbtack needle (TN) and Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN) in Diminished Ovarian Reserve (DOR) and Infertility (IVF Patients), sponsored by Huazhong University of Science and Technology. Not yet recruiting at 4 sites in China. Open to female participants aged 20 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to examine the effect of ETN on live birth rate in patients with diminished ovarian reserve (DOR) undergoing in vitro fertilizitaion-embryo transfer (IVF-ET). Four hundred and six patients with DOR will be enrolled randomly divided into treatment group and control group, with 203 patients in each group. The treatment group will receive electro-thumbtack needle (ETN) therapy, while the control group received placebo ETN. Both groups initiated treatment 1 to 3 menstrual cycles before IVF-ET and continued until the intramuscular injection of HCG (night injection) during the IVF cycle. The study will observe and compare the pregnancy outcomes (including live birth rate, clinical pregnancy rate, biochemical pregnancy rate, threatened abortion, abortion, oocyte retrieval, and embryo quality), ovarian reserve function, anxiety, depression, sleep status, and quality of life between the two groups.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 406 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Huazhong University of Science and Technology is the lead sponsor of 247 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment of electro-thumbtack needle (ETN) / thumbtack needle (TN)
Device: electro-thumbtack needle (ETN) / thumbtack needle (TN)
Treatment of sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)
Device: Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)
The following 12 acupoints including conception vessel (CV) 4, CV3, bilateral ovary acupoints (3 cun below the umbilicus and 3 cun lateral to the anterior midline), 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 (TN) for single use , and four points of bilateral ovary acupoints and bilateral EX-B7 were treated by disposable sterile electro-thumbtack needle (ETN). Electrode pads are attached on the ETN and connected to the electroacupuncture apparatus. Medium-intensity stimulation is applied for 15 minutes. After stimulation, the electroacupuncture apparatus and electrode pads are removed, but the ETN remain in place for 5 - 7 days. During the needle retention period, the abdominal ovary acupoints and the back EX-B7 are stimulated alternately every day for 15 minutes each time using the electroacupuncture apparatus device.
The control group was selected with the same acupoints as the treatment group. The practitioner disinfected both hands and strictly sterilized the local skin of the acupoints, then attached sham ETN and sham TN to the surface of the acupoints. The stimulation methods and frequencies of sham ETN and sham TN were identical to those used in the treatment group.
Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion
Time frame: At birth
Clinical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion
Time frame: About 28 days after embryo transfer
Biochemical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion
Time frame: About 14 days after embryo transfer
The rate of miscarriage in pregnant patients who underwent their first embryo transfer in IVF-ET after the completion of treatment
Time frame: During the whole period of pregnancy, assessed up to 40 weeks
The rate of threatened miscarriage in pregnant patients who underwent their first embryo transfer in the first IVF-ET after treatment completion
Time frame: During the whole period of pregnancy, assessed up to 40 weeks
Pregnancy complications in patients who underwent their first embryo transfer in IVF-ET after the completion of treatment
Time frame: During the whole period of pregnancy, assessed up to 40 weeks
Serum level of six sex hormones
Time frame: At baseline, and one month after the treatment
Antral follicle count (AFC) in both ovaries
Time frame: At baseline, and one month after the treatment
Serum level of Anti-Müllerian Hormone (AMH)
Time frame: At baseline, and one month after the treatment
Number of oocytes and MII oocyte ratio retrieved on the first IVF-ET after treatment
Time frame: On the day of oocyte retrieval during IVF-ET
Embryo status in the first IVF-ET after treatment
Time frame: One week after oocyte retrieval during the IVF-ET
Depression assessment using the Zung Depression Self-Rating Scale (Zung-SDS)
Time frame: At baseline, and one week after the treatment
Anxiety assessment using the Zung Anxiety Self-Rating Scale (Zung-SAS)
Time frame: At baseline, and one week after the treatment
Assessment of quality of life (QOL) using MOS 36-Item Short Form Health Survey (SF-36)
Time frame: At baseline, and one week after the treatment
Sleep quality survey using Pittsburgh Sleep Quality Index (PSQI)
Time frame: At baseline, and one week after the treatment
Untargeted metabolomics analysis of blood
Time frame: At baseline, and one month after the treatment
Detection of cytokines in follicular fluid collected during the first IVF-ET after treatment
Time frame: On the day of oocyte retrieval during IVF-ET
Proteomic analysis of granulosa cells collected from the first IVF-ET after treatment
Time frame: On the day of oocyte retrieval during IVF-ET
Untargeted metabolomics analysis of follicular fluid collected from the first IVF-ET after treatment
Time frame: On the day of oocyte retrieval during IVF-ET
The health status of the offspring of the first embryo transfer in the first IVF-ET, including gestational age at birth, infant weight and height, presence of malformations, neonatal jaundice, hypoglycemia, etc
Time frame: 42 days after live birth
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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