Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve
- Conditions
- Diminished Ovarian Reserve
- Interventions
- Other: Treatment group protocolOther: Control group protocol
- Registration Number
- NCT04972877
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief Summary
Diminished ovarian reserve (DOR) is the precursor state of ovarian failure, and can cause the decline of women's reproductive function. Some studies have demonstrated that acupuncture can improve ovarian function. In this trial, we hypothesize that electro-acupuncture is efficient for the ovarian function and the following outcome of IVF-ET in DOR patients.
- Detailed Description
First, patients will be recruited according to the inclusion criteria and exclusion criteria.
Second, baseline measurements (including ovarian reserve function, blood biochemical index, scores from the self-rating anxiety and depression scale, quality of life) will be taken.
Third, each patient will receive 24 sessions of acupuncture in 2-3 months, twice or three times a week.
Last, the above baseline measurements will be taken again as soon as the treatment is finished and outcome measures will be recorded after the treatment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 338
- Age < 40, will undergo IVF-ET;
- Low ovarian reserve: Antral follicle count (AFC)<7, or AMH<1.1ng/ml; or has a history of poor ovarian response: in the last hyper stimulation cycle, the number of retrieved oocytes<3;
- Spouse' semen examination is normal, or after semen prewash can reach the standard of common IVF or Intracytoplasmic Sperm Injection(ICSI).
- Male with azoospermia;
- Male/female's chromosome is abnormal;
- Adenomyosis, uterine fibroids, endometrial polyps, scar uterine, reproductive system tuberculosis, oviduct effusion, pelvic lesions such as ovarian endometriosis cyst or tumor;
- Female has other endocrine disease: thyroid diseases, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
- Definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome;
- Other pathogenesis that leads to recurrent miscarriage or agnogenic recurrent miscarriage;
- A history of cancer and has received radiotherapy and chemotherapy;
- Had acupuncture treatment in recent 3 months;
- Unwilling to sign the informed consent of this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group Treatment group protocol Treatment group protocol：participants will receive electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes. Control group Control group protocol Control group protocol：participants will receive sham electro-acupuncture twice or three times a week with a maximum of 24 times in 2-3 months. Each treatment session lasts for 30 minutes.
- Primary Outcome Measures
Name Time Method Assessing the change of ovarian reserve function 0 week and up to 4 weeks Assessing patients' ovarian reserve function before and after electro-acupuncture intervention, including: (1) The serum AMH, inhibin, and FSH and E2 levels on the third day of menstruation;(2) AFC.
- Secondary Outcome Measures
Name Time Method Clinical pregnancy rate through study completion, an average of 1 year the clinical pregnancy rate per cycle of IVF-ET after electro-acupuncture.
Outcomes of IVF through study completion, an average of 1 year 1. Gn dosage(U/d) and usage days;
2. E2 level(pg/ml) and endometrial thickness(mm) on human chorionic gonadotropin (HCG) day;
3. number of oocytes;
4. MII oocytes;
5. normal fertility rate;
6. the number of available embryos;
7. number of high-quality embryos;
8. cycle cancellation rate (including cycle cancellation rate caused by various reasons);
9. implantation rate: including fresh periodic implantation rate, per cycle implantation rate and cumulative implantation rate;
10. fresh cycle clinical pregnancy rate and cycle cumulative clinical pregnancy rate;
11. early, mid and late pregnancy abortion rate;
12. risk of ovarian hypertrophy and incidence of obstetric complications;
13. FSH(mIU/ml), LH(mIU/ml), E2(pg/ml) and AMH(ng/ml) in follicular fluid; Oxidative stress related indicators such as reactive oxygen species (ROS), superoxide dismutase (SOD) level, etc.;
14. live rate: including fresh cycle live rate, cycle live rate and cumulative live rate.Blood biochemical index examination 0 week and up to 12 weeks Testing the levels of blood corticotrophin-releasing hormone (CRH), norepinephrine, adrenaline, 5-hydroxytryptamine, beta-aminobutyric acid (GABA), dopamine (DA) and neuro-endorphin of the patients before and after treatment.
Questionnaires 0 week and up to 4 weeks Evaluation of anxiety, depression, quality of life and sleep state is performed before and after treatment.
1. Baker anxiety self-rating scale (BAI) and baker depression self-rating scale (BDI-Ⅱ) : higher score indicates higher degree of depression or anxiety \[12-13\].
2. Zung anxiety self-rating scale (Zung-SAS), Zung depression self-rating scale (Zung-SDS) \[14-15\].
3. Quality of life measurement (QOL): Quality of life will be assessed by SF-36 and Chinese quality of life scale (CHQOL).
4. Self-Rating Scale of Sleep (SRSS), sleep dysfunction rating scale (SDRS), Pittsburgh sleep quality index (PSQI).Follow-up detection through study completion, an average of 1 year Pregnancy patients will be followed up to the end of pregnancy. Adverse pregnancy outcomes and live birth rates will be recorded. Non-pregnant patients will be followed up for 1 year after treatment, testing the ovarian reserve function, follow-up treatment and pregnancy status of the patients within 1 year.
Trial Locations
- Locations (1)
Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China