NCT07769684

Brief 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). 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
65mo left

Started Aug 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Aug 2026Dec 2031

First Submitted

Initial submission to the registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

4.5 years

First QC Date

July 23, 2026

Last Update Submit

August 12, 2026

Conditions

Diminished Ovarian Reserve (DOR)Infertility (IVF Patients)

Keywords

Diminished ovarian reserveIVF-ETLive birth rateElectro-thumbtack needle

Outcome Measures

Primary Outcomes (1)

  • Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion

    At birth

Secondary Outcomes (19)

  • Clinical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion

    About 28 days after embryo transfer

  • Biochemical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion

    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

    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

    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

    During the whole period of pregnancy, assessed up to 40 weeks

  • +14 more secondary outcomes

Study Arms (2)

treatment group

ACTIVE COMPARATOR

Treatment of electro-thumbtack needle (ETN) / thumbtack needle (TN)

Device: electro-thumbtack needle (ETN) / thumbtack needle (TN)

control group

SHAM COMPARATOR

Treatment of sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)

Device: Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)

Interventions

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.

treatment group
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.

control group

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age between 20-42 years old;
  • \. 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.
  • \. 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%;
  • \. Intend to undergo In Vitro Fertilization - Embryo Transfer (IVF-ET);
  • \. Voluntarily participate in this study, sign the informed consent form, and be able to cooperate to complete the treatment and follow-up.

You may not qualify if:

  • \. Chromosomal or genetic abnormalities in the female or male partner;
  • \. History of ovarian surgery, such as surgery for ovarian teratomas or ovarian chocolate cysts;
  • \. Uterine abnormalities that may affect embryo implantation (including uterine malformations, uterine tuberculosis, adenomyosis, and submucosal myomas \>4 cm);
  • \. Unresolved intrauterine adhesions, endometritis, or endometrial polyps;
  • \. 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;
  • \. 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;
  • \. Three or more failed embryo transfers;
  • \. History of malignant tumors in the female or male partner with prior radiotherapy or chemotherapy;
  • \. The female partner has received acupuncture or press needle therapy in the past 3 months;
  • \. Use of Chinese herbal decoctions or granules during treatment;
  • \. Abnormal semen analysis in the male partner;
  • \. Refusal to undergo in vitro fertilization - embryo transfer (IVF-ET);
  • \. Refusal to sign the informed consent form for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Shiyan People's Hospital

Shiyan, Hubei, 442000, China

Location

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine

Wuhan, Hubei, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Dongmei Huang, Doctor

CONTACT

+86 27 83663275hdmjcr@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 18, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

August 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

CN(4)