Diminished Ovarian Reserve (DOR)ETN-LBR-DORNCT07769684
RCT Study on the Effect of ETN on Live Birth Rate in DOR Patients Undergoing IVF-ET
A study testing electro-thumbtack needle (ETN) / thumbtack needle (TN) in people with Diminished Ovarian Reserve (DOR) and Infertility (IVF Patients), run by Huazhong University of Science and Technology at 4 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR), Infertility (IVF Patients)
- What is being tested?
- electro-thumbtack needle (ETN) / thumbtack needle (TN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 406 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Age between 20-42 years old;
- 2. Meet the DOR diagnostic criteria: Diagnosis of diminished ovarian reserve (DOR) can be made if any two of the following three criteria are met: ①Serum AMH level ≤ 1.1 ng/mL; ②On days 2-4 of the menstrual cycle, transvaginal ultrasound demonstrates a total number of basal antral follicles (diameter 2-10 mm) in both ovaries <7 (antral follicle counting, AFC); ③For two consecutive menstrual cycles, on days 2-4, serum FSH levels range from 10 U/L to <25 U/L.
- 3. Semen routine examination of the participant's spouse is normal: sperm concentration ≥15×10⁶/mL, proportion of forward-moving sperm ≥32%, proportion of normally shaped sperm ≥4%;
- 4. Intend to undergo In Vitro Fertilization - Embryo Transfer (IVF-ET);
- 5. Voluntarily participate in this study, sign the informed consent form, and be able to cooperate to complete the treatment and follow-up.
Who cannot join
- 1. Chromosomal or genetic abnormalities in the female or male partner;
- 2. History of ovarian surgery, such as surgery for ovarian teratomas or ovarian chocolate cysts;
- 3. Uterine abnormalities that may affect embryo implantation (including uterine malformations, uterine tuberculosis, adenomyosis, and submucosal myomas >4 cm);
- 4. Unresolved intrauterine adhesions, endometritis, or endometrial polyps;
- 5. The female partner has uncorrected endocrine disorders such as uncomplicated hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, or has taken antipsychotic medications in the past 3 months;
- 6. The female partner has a confirmed diagnosis of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjögren's syndrome, or Hashimoto's thyroiditis;
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- 7. Three or more failed embryo transfers;
- 8. History of malignant tumors in the female or male partner with prior radiotherapy or chemotherapy;
- 9. The female partner has received acupuncture or press needle therapy in the past 3 months;
- 10. Use of Chinese herbal decoctions or granules during treatment;
- 11. Abnormal semen analysis in the male partner;
- 12. Refusal to undergo in vitro fertilization - embryo transfer (IVF-ET);
- 13. Refusal to sign the informed consent form for this study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Shiyan People's Hospital
Shiyan, Hubei, 442000
Yuhong Dr. Zhang, Bachelor, 86 18671988831, 337349125@qq.com
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Dongmei Huang, Doctor, 86 027-83663275, hdmjcr@qq.com
Jihui Ai, Doctor
Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine
Wuhan, Hubei
Qingchun Xie, Bachelor, 86 15271931822, 7725553@qq.com
Xiangyang Central Hospital
Xiangyang, Hubei
Xuezhou Dr. Yang, Doctor, 86 18671019865, 916669206@qq.com
Xuezhou Yang, Doctor
About this study
Official title: Effect of Electro-thumbtack Needle (ETN) on Live Birth Rate in Patients With Diminished Ovarian Reserve (DOR) Undergoing IVF-ET: A Multicenter Randomized Controlled Clinical Trial
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.
- Being tested
- electro-thumbtack needle (ETN) / thumbtack needle (TN), Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)
- Keywords
- Diminished ovarian reserve, IVF-ET, Live birth rate, Electro-thumbtack needle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-thumbtack needle (ETN) / thumbtack needle (TN)Device
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.
Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | Treatment of electro-thumbtack needle (ETN) / thumbtack needle (TN) Receives: Device: electro-thumbtack needle (ETN) / thumbtack needle (TN) |
| control group | Sham comparator | Treatment of sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN) Receives: Device: Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion
Measured: At birth
Secondary outcomes (19)
Clinical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion
Measured: About 28 days after embryo transfer
Biochemical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion
Measured: 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
Measured: 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
Measured: 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
Measured: During the whole period of pregnancy, assessed up to 40 weeks
Serum level of six sex hormones
Measured: At baseline, and one month after the treatment
Antral follicle count (AFC) in both ovaries
Measured: At baseline, and one month after the treatment
Serum level of Anti-Müllerian Hormone (AMH)
Measured: At baseline, and one month after the treatment
Number of oocytes and MII oocyte ratio retrieved on the first IVF-ET after treatment
Measured: On the day of oocyte retrieval during IVF-ET
Embryo status in the first IVF-ET after treatment
Measured: One week after oocyte retrieval during the IVF-ET
Depression assessment using the Zung Depression Self-Rating Scale (Zung-SDS)
Measured: At baseline, and one week after the treatment
Anxiety assessment using the Zung Anxiety Self-Rating Scale (Zung-SAS)
Measured: At baseline, and one week after the treatment
Assessment of quality of life (QOL) using MOS 36-Item Short Form Health Survey (SF-36)
Measured: At baseline, and one week after the treatment
Sleep quality survey using Pittsburgh Sleep Quality Index (PSQI)
Measured: At baseline, and one week after the treatment
Untargeted metabolomics analysis of blood
Measured: At baseline, and one month after the treatment
Detection of cytokines in follicular fluid collected during the first IVF-ET after treatment
Measured: On the day of oocyte retrieval during IVF-ET
Proteomic analysis of granulosa cells collected from the first IVF-ET after treatment
Measured: On the day of oocyte retrieval during IVF-ET
Untargeted metabolomics analysis of follicular fluid collected from the first IVF-ET after treatment
Measured: 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
Measured: 42 days after live birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Feb 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian Reserve (DOR)Studies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongmei Huang, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769684
- Sponsor's protocol ID
- ETN-LBR-DOR-IVF
- Other IDs
- 2024TJCR011, 82374258
- Acronym
- ETN-LBR-DOR
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electro-thumbtack Needle (ETN) on Live Birth Rate in Patients With Diminished Ovarian Reserve (DOR) Undergoing IVF-ET: A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07769684
- Acronym / sponsor ID
- ETN-LBR-DOR / ETN-LBR-DOR-IVF
- Keywords
- Diminished ovarian reserve, IVF-ET, Live birth rate, Electro-thumbtack needle
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Device: electro-thumbtack needle (ETN) / thumbtack needle (TN)Treatment of electro-thumbtack needle (ETN) / thumbtack needle (TN) |
| control group | Sham comparator | Device: Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)Treatment of sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN) |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Age between 20-42 years old;
- 2. Meet the DOR diagnostic criteria: Diagnosis of diminished ovarian reserve (DOR) can be made if any two of the following three criteria are met: ①Serum AMH level ≤ 1.1 ng/mL; ②On days 2-4 of the menstrual cycle, transvaginal ultrasound demonstrates a total number of basal antral follicles (diameter 2-10 mm) in both ovaries <7 (antral follicle counting, AFC); ③For two consecutive menstrual cycles, on days 2-4, serum FSH levels range from 10 U/L to <25 U/L.
- 3. Semen routine examination of the participant's spouse is normal: sperm concentration ≥15×10⁶/mL, proportion of forward-moving sperm ≥32%, proportion of normally shaped sperm ≥4%;
- 4. Intend to undergo In Vitro Fertilization - Embryo Transfer (IVF-ET);
- 5. Voluntarily participate in this study, sign the informed consent form, and be able to cooperate to complete the treatment and follow-up.
Key exclusion criteria (13 listed)
- 1. Chromosomal or genetic abnormalities in the female or male partner;
- 2. History of ovarian surgery, such as surgery for ovarian teratomas or ovarian chocolate cysts;
- 3. Uterine abnormalities that may affect embryo implantation (including uterine malformations, uterine tuberculosis, adenomyosis, and submucosal myomas >4 cm);
- 4. Unresolved intrauterine adhesions, endometritis, or endometrial polyps;
- 5. The female partner has uncorrected endocrine disorders such as uncomplicated hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, or has taken antipsychotic medications in the past 3 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electro-thumbtack needle (ETN) / 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. | Device | treatment group |
| Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)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. | Device | control group |
Primary outcome
Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion
Time frame: At birth
19 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electro-thumbtack needle (ETN) / thumbtack needle (TN) in people with Diminished Ovarian Reserve (DOR) and Infertility (IVF Patients), run by Huazhong University of Science and Technology at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Huang, Doctor (+86 27 83663275, hdmjcr@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.