Clinical trial NCT04972877: Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve
Official title: Effect of Electro-acupuncture on Ovarian Function and Outcome of IVF-ET of Women With Diminished Ovarian Reserve：a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diminished Ovarian Reserve
Keywords: Electro-acupuncture
Diminished ovarian reserve
In vitro fertilization-embryo transfer
Randomized controlled trial
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan No.1 Hospital
name: Wuhan Union Hospital, China
name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
name: Edwatz Medical Research Institude
name: Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine
First posted: 2021-07-22
Enrollment: 338
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessing the change of ovarian reserve function
timeFrame: 0 week and up to 4 weeks
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: through study completion, an average of 1 year
measure: Outcomes of IVF
timeFrame: through study completion, an average of 1 year
measure: Blood biochemical index examination
timeFrame: 0 week and up to 12 weeks
measure: Questionnaires
timeFrame: 0 week and up to 4 weeks
measure: Follow-up detection
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology
name: Dongmei Huang, doctor
role: PRINCIPAL_INVESTIGATOR
References: