Diminished Ovarian Reserve (DOR), Infertility (IVF Patients)
Conditions
Keywords
Diminished ovarian reserve, IVF-ET, Live birth rate, Electro-thumbtack needle
Brief 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.
Interventions
DEVICEelectro-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.
DEVICESham 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
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No
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 \<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); * 5\. Voluntarily participate in this study, sign the informed consent form, and be able to cooperate to complete the treatment and follow-up.
Exclusion criteria
* 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; * 5\. The female partner has uncorrected endocrine disorders such as uncomplicated hyperthyroidism or hypothyroidism, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, or has taken antipsychotic medications in the past 3 months; * 6\. The female partner has a confirmed diagnosis of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, Sjögren's syndrome, or Hashimoto's thyroiditis; * 7\. Three or more failed embryo transfers; * 8\. History of malignant tumors in the female or male partner with prior radiotherapy or chemotherapy; * 9\. The female partner has received acupuncture or press needle therapy in the past 3 months; * 10\. Use of Chinese herbal decoctions or granules during treatment; * 11\. Abnormal semen analysis in the male partner; * 12\. Refusal to undergo in vitro fertilization - embryo transfer (IVF-ET); * 13\. Refusal to sign the informed consent form for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate of the first embryo transplantation in patients undergoing the first IVF-ET after treatment completion | At birth |
Secondary
| Measure | Time frame |
|---|---|
| Number of oocytes and MII oocyte ratio retrieved on the first IVF-ET after treatment | On the day of oocyte retrieval during IVF-ET |
| Embryo status in the first IVF-ET after treatment | One week after oocyte retrieval during the IVF-ET |
| Depression assessment using the Zung Depression Self-Rating Scale (Zung-SDS) | At baseline, and one week after the treatment |
| Anxiety assessment using the Zung Anxiety Self-Rating Scale (Zung-SAS) | At baseline, and one week after the treatment |
| Assessment of quality of life (QOL) using MOS 36-Item Short Form Health Survey (SF-36) | At baseline, and one week after the treatment |
| Sleep quality survey using Pittsburgh Sleep Quality Index (PSQI) | At baseline, and one week after the treatment |
| Untargeted metabolomics analysis of blood | At baseline, and one month after the treatment |
| Detection of cytokines in follicular fluid collected during the first IVF-ET after treatment | On the day of oocyte retrieval during IVF-ET |
| Proteomic analysis of granulosa cells collected from the first IVF-ET after treatment | On the day of oocyte retrieval during IVF-ET |
| Untargeted metabolomics analysis of follicular fluid collected from the first IVF-ET after treatment | On the day of oocyte retrieval during IVF-ET |
| The health status of the offspring of the first embryo transfer in the first IVF-ET, including gestational age at birth, infant weight and height, presence of malformations, neonatal jaundice, hypoglycemia, etc | 42 days after live birth |
| Antral follicle count (AFC) in both ovaries | At baseline, and one month after the treatment |
| Clinical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion | About 28 days after embryo transfer |
| Biochemical pregnancy rate of the first embryo transfer in patients undergoing the first IVF-ET after treatment completion | About 14 days after embryo transfer |
| The rate of miscarriage in pregnant patients who underwent their first embryo transfer in IVF-ET after the completion of treatment | During the whole period of pregnancy, assessed up to 40 weeks |
| The rate of threatened miscarriage in pregnant patients who underwent their first embryo transfer in the first IVF-ET after treatment completion | During the whole period of pregnancy, assessed up to 40 weeks |
| Pregnancy complications in patients who underwent their first embryo transfer in IVF-ET after the completion of treatment | During the whole period of pregnancy, assessed up to 40 weeks |
| Serum level of Anti-Müllerian Hormone (AMH) | At baseline, and one month after the treatment |
| Serum level of six sex hormones | At baseline, and one month after the treatment |
Countries
China
Contacts
CONTACTDongmei Huang, Doctor
Outcome results
None listed