Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve

NCT ID: NCT04972877

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2025-12-31

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.

Conditions

Diminished Ovarian Reserve

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group

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.

Group Type: ACTIVE_COMPARATOR

Treatment group protocol

Intervention Type: OTHER

For treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25*40/50 mm) will be inserted into a depth of 15~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke "Deqi" every 10 minutes.

The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group.

Control group

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.

Group Type: SHAM_COMPARATOR

Control group protocol

Intervention Type: OTHER

For control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18\*25 mm) will be inserted superficially to a depth of \< 5 mm without any manual stimulus and the needle sensation ("Deqi" in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes.

Interventions

Treatment group protocol

For treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25*40/50 mm) will be inserted into a depth of 15~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke "Deqi" every 10 minutes.

The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group.

Intervention Type: OTHER

Control group protocol

For control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18\*25 mm) will be inserted superficially to a depth of \< 5 mm without any manual stimulus and the needle sensation ("Deqi" in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wuhan No.1 Hospital

OTHER

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Edwatz Medical Research Institude

UNKNOWN

Sponsor Role: collaborator

Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine

UNKNOWN

Sponsor Role: collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Dongmei Huang

Department of Integrated Traditional Chinese and Western Medicine Tongji hospital Affiliation: Huazhong University of Science and Technology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dongmei Huang, doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology

Locations

Department of Integrated Traditional Chinese and Western Medicine Tongji hospital of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dongmei Huang, doctor

Role: CONTACT

hdmjcr@qq.com

13971578190 ext. 02783663275

Hanwang Zhang, doctor

Role: CONTACT

hwzhang605@126.com

13386151967

Facility Contacts

Dongmei Huang

Role: primary

hdmjcr@qq.com

13971578190

Other Identifiers

TJ-IRB20190620

Identifier Type: -

Identifier Source: org_study_id