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RCT Study on the Effect of ETN on Live Birth Rate in DOR Patients Undergoing IVF-ET

NCT07769684 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Diminished Ovarian Reserve (DOR)
  • Infertility (IVF Patients)

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2031-02-01
Completion
2031-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769684 on ClinicalTrials.gov