Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Diminished Ovarian Reserve

Treatments: Other: Control group protocol; Other: Treatment group protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04972877

TJ-IRB20190620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 338 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age < 40, will undergo IVF-ET;
2. 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;
3. Spouse' semen examination is normal, or after semen prewash can reach the standard of common IVF or Intracytoplasmic Sperm Injection(ICSI).

Exclusion criteria

1. Male with azoospermia;
2. Male/female's chromosome is abnormal;
3. Adenomyosis, uterine fibroids, endometrial polyps, scar uterine, reproductive system tuberculosis, oviduct effusion, pelvic lesions such as ovarian endometriosis cyst or tumor;
4. Female has other endocrine disease: thyroid diseases, hyperprolactinemia, insulin resistance, diabetes, adrenal diseases, etc.
5. Definitively diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome;
6. Other pathogenesis that leads to recurrent miscarriage or agnogenic recurrent miscarriage;
7. A history of cancer and has received radiotherapy and chemotherapy;
8. Had acupuncture treatment in recent 3 months;
9. Unwilling to sign the informed consent of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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338 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

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.

Treatment:

Other: Treatment group protocol

Control group

Sham Comparator group

Description:

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.

Treatment:

Other: Control group protocol