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

ConditionsDiminished Ovarian Reserve (DOR)Infertility (IVF Patients)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-42
SponsorHuazhong University of Science and Technology

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

406 Participants
are divided into 2 treatment groups
Group A: treatment groupActive comparator 1 intervention
Group B: control groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At birth

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: