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NCT07769684
RCT Study on the Effect of ETN on Live Birth Rate in DOR Patients Undergoing IVF-ET
Conditions: Diminished Ovarian Reserve (DOR), Infertility (IVF Patients)
Sex: Female
Ages: 20 Years – 42 Years
Healthy volunteers: No
Phase: NA
Enrollment: 406
Sponsor: Huazhong University of Science and Technology
Location: Shiyan People's Hospital Shiyan Hubei
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.
Eligibility Criteria
Inclusion Criteria:
* 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 \
Source: ClinicalTrials.gov (NCT07769684). StuddyBuddy aggregates publicly available trial information.