The Clinical Trial of Electro-thumbtack Needle on Live Birth Rate in Patients With Ovarian Reserve Dysfunction (DOR)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorHuazhong University of Science and Technology

About this trial

This study will include 246 patients with ovarian reserve dysfunction (DOR), who will be randomly divided into a treatment group and a control group, with 123 patients in each group. The treatment group will receive electro-thumbtack needle treatment, while the control group will receive placebo electro-thumbtack needle treatment. Both groups will receive a treatment course of 3 menstrual cycles. This study evaluates the effect of electrocautery on the live birth rate of patients with DOR.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The age range is 18-40 years old;

Meets the diagnostic criteria for DOR as follows: ① AMH<1.1 ng/ml; ② 10 U/L < FSH < 25U/L or FSH/LH > 3.6; ③ The total number of follicles (AFC) in both basal sinuses is less than 7. If any two of the above criteria (①②③) are met, it can be diagnosed as DOR.

At least one side of the patient's fallopian tube is unobstructed;

The semen routine examination of the patient's spouse is normal;

Disqualifiers

Chromosomal or genetic abnormalities in either the female or male partner;

Women with blocked fallopian tubes on both sides;

Have a history of ovarian surgery, such as ovarian teratoma or ovarian chocolate cyst surgery;

The female party suffers from uncorrected endocrine disorders such as simple hyperthyroidism or hypothyroidism, hyperprolactinemia, and pancreatic islet dysfunction;

Trial design

Design model

Parallel

Treatments tested in this trial

  • electro-thumbtack needle

    Other intervention

    The treatment acupoints include bilateral ovarian acupoints, Guan Yuan (CV4), bilateral Shen Shu (BL23), bilateral waist and eye acupoints (EX-B7), bilateral San Yin Jiao (SP6), and bilateral Zu San Li (ST36), totaling 11 acupoints. Among them, the bilateral ovarian acupoints and bilateral waist eye acupoints (EX-B7) were treated with electro-thumbtack needle. Other acupoints were treated with thumbtack needle.Choose a sparse and dense waveform, adjust the intensity to the maximum patient can tolerate, and stimulate for 30 minutes each time. After the stimulation is completed, remove the electrode patch and electroacupuncture device, and keep the electric needle at the acupoint for another 3 days.During the needle retention period, the electric needles at the bilateral ovarian acupoints and bilateral waist and eye acupoints were alternately stimulated once every other day using an electroacupuncture device for 30 minutes each time.

  • placebo electro-thumbtack needle

    Other intervention

    The control group selected acupoints that were the same as the treatment group. Bilateral ovarian acupoints and bilateral waist and eye acupoints are treated with placebo electro-thumbtack needle, while other acupoints are treated with placebo electro-thumbtack needle. The treatment methods for placebo electro-thumbtack needle and placebo thumbtack needle are the same as those for the treatment group.

Treatment groups

368 Participants
are divided into 2 treatment groups
Group A: electro-thumbtack needle groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

live birth rate

The live birth rate is defined as the proportion of live births after 28 weeks of pregnancy, usually calculated by dividing the number of live birth cycles by the total number of patients and multiplying by 100%. This indicator is commonly used to evaluate the effectiveness of reproductive health centers or specific treatment methods, reflecting the ultimate outcome of successful pregnancy.

Time frame
3 months

Secondary outcomes

1

Biochemical pregnancy rate

Biochemical pregnancy, also known as subclinical miscarriage or occult miscarriage, refers to the phenomenon where the embryo fails to successfully implant on the uterine wall in the early stages, leading to termination of pregnancy.The biochemical pregnancy rate is calculated by dividing the number of biochemical pregnancies by the total number of patients.

Time frame
3 months
2

clinical pregnancy rate

Clinical pregnancy refers to the presence of a gestational sac in the uterine cavity, as well as the appearance of fetal buds and primitive heartbeats, observed through ultrasound examination in the early stages of pregnancy. These signs indicate normal implantation and development of the embryo, confirming a normal intrauterine pregnancy.The clinical pregnancy rate is calculated by dividing the number of pregnancies by the total number of patients.

Time frame
3 months
3

Threatened miscarriage rate

Threatened miscarriage refers to symptoms such as vaginal bleeding and abdominal pain that occur before 28 weeks of pregnancy, but at this time the cervix is not open, the membranes are intact, there is no discharge of pregnancy material, and the size of the uterus matches the gestational age. The threatened miscarriage rate is calculated by dividing the number of threatened miscarriages by the total number of patients.

Time frame
3 months
4

abortion rate

The miscarriage rate is calculated by dividing the number of miscarriages by the total number of patients.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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