RCT Study on the Effect of ETN on Live Birth Rate in DOR Patients Undergoing IVF-ET
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
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
Treatments tested in this trial
- electro-thumbtack needle (ETN) / thumbtack needle (TN)
- Sham electro-thumbtack needle (ETN) / sham thumbtack needle (TN)
Treatment groups
406 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov