Women with infertility due to diminished ovarian reserve including those with or without transferable embryos Pregnancy and Childbirth
Conditions
Interventions
Current interventions as of 02/12/2024:
Eligible patients will be randomly allocated to either the electro-acupuncture (EA) group or the sham electro-acupuncture (SA). The SPSS software version 26.0 w
CV 4, CV 3, and EX-CA 1 will be punctured perpendicularly or obliquely at a depth of 25-40 mm
ST 36 and SP 6 will be punctured perpendicularly at a depth of 25-50 mm
GV 20 and GV 24 will be punctured horizontally or obliquely at a depth of 10-20 mm. Acupunc
Sponsors
Shenzhen Municipal People's Government
Shenzhen Luohu District Science and Technology Innovation Bureau
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 02/12/2024: 1. Women aged 20 to 48 years 2. Conforming to the clinical diagnostic criteria for DOR 3. Voluntary and written informed consent Previous inclusion criteria: 1. Women aged 20 to 42 years 2. Conforming to the clinical diagnostic criteria for DOR 3. Voluntary and written informed consent
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 02/12/2024: 1. Endocrine disorders such as hyperprolactinemia, hyperandrogenemia, chronic adrenal insufficiency, and severe thyroid dysfunction. 2. Reproductive system anomalies such as severe hydrosalpinx, significant tubal or pelvic adhesions, and myomas invading the endometrium, which adversely affect the outcome of pregnancies. 3. Immune system disorders such as immune nephritis and systemic lupus erythematosus, which may lead to infertility. 4. Contraindications to pregnancy or uterine non-viability for gestation. 5. Infertility attributable to congenital malformations of the reproductive system, chromosomal anomalies, or other genetic etiologies. 6. Severe comorbidities including serious cardiovascular, hepatic, renal, hematopoietic system diseases, malignancies, and mental health disorders. 7. Received DOR-related interventions within 3 months. 8. Deemed unsuitable for participation in the trial by the researcher. Previous exclusion criteria: 1. Male factor infertility characterized by severe oligospermia, asthenospermia, necrospermia, teratospermia, or azoospermia 2. Conditions such as severe hydrosalpinx, significant tubal or pelvic adhesions, and myomas invading the endometrium, which adversely affect the outcome of IVF pregnancies 3. Immune system disorders such as immune nephritis and systemic lupus erythematosus, which may lead to infertility 4. Endocrinopathies such as hyperprolactinemia, hyperandrogenemia, chronic adrenal insufficiency, and marked thyroid dysfunction 5. Infertility attributable to congenital malformations of the reproductive system, chromosomal anomalies, or other genetic etiologies 6. Coexistence of severe cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic disorders, malignant neoplasms, or psychiatric conditions. 7. Contraindications to pregnancy or uterine non-viability for gestation 8. Received DOR-related interventions (ie. drugs, acupuncture, herbs, etc) within 4 weeks 9. Subjects considered ineligible for trial participation based on researcher evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 02/12/2024: Antral follicle count measured using ultrasound at baseline and after 12 weeks of treatment Previous primary outcome measure: Clinical pregnancy rate measured using data collection about on-site visits, telephone calls, or WeChat communications at 4 to 7 weeks after embryo transfer | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/12/2024: 1. Anti-Müllerian hormone measured using blood samples at baseline and after 12 weeks of treatment 2. Basal hormone levels (follicle-stimulating hormone, estradiol, luteinizing hormone, FSH/LH ratio) measured using blood samples at baseline and after 12 weeks of treatment 3. Anxiety, depression, and menopause symptoms measured using the Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and Modified Kupperman Index scores at baseline and after 12 weeks of treatment. 4. Endometrial thickness and morphology measured using ultrasound on the day of embryo transfer 5. Patients undergoing ovulation induction cycles: the following indicators are measured using data collection within 1 to 7 days after ovulation: 5.1. Gonadotropin (Gn) usage 5.2. Oocyte retrieval 5.3. Fertilization rate 5.4. Cleavage rate 5.5. Morphological assessment of oocytes 5.6. Day 3 high-quality embryo rate 5.7. Day 3 utilizable embryo rate 5.8. Blastocyst formation rate 5.9. High-quality blastocyst rate 5.10 MII oocyte rate 6. Pregnancy outcomes are assessed using data collection about on-site visits, telephone calls, and WeChat communications up to 12 months after treatment, with a maximum follow-up duration of 12 months post-treatment: 6.1. Clinical pregnancy rate 6.2. Biochemical pregnancy rate 6.3. Live birth rate 6.4. Miscarriage rate Previous secondary outcome measures: 1. Biochemical pregnancy rate measured using data collection about on-site visits, telephone calls, and WeChat communications at 2 weeks after embryo transfer 2. Live birth rate measured using data collection about on-site visits, telephone calls and WeChat communications monthly until the end of pregnancy 3. Miscarriage rate measured using data collection about on-site visits, telephone calls and WeChat communications monthly until the end of pregnancy 4. Anti-Müllerian hormone measured using blood samples at baseline and after 8 weeks of treatment 5. Basi | — |
Countries
China
Contacts
Public ContactZhao Hong
Outcome results
None listed