Effect of Electro-acupuncture on Women With Diminished Ovarian Reserve

NCT04972877 | Unknown

• 1 other identifier: TJ-IRB20190620
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Diminished Ovarian Reserve

Keywords

Electro-acupuncture; Diminished ovarian reserve; In vitro fertilization-embryo transfer; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Assessing the change of ovarian reserve function

  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.

  0 week and up to 4 weeks

Secondary Outcomes (5)

• Clinical pregnancy rate

  through study completion, an average of 1 year

• Outcomes of IVF

  through study completion, an average of 1 year

• Blood biochemical index examination

  0 week and up to 12 weeks

• Questionnaires

  0 week and up to 4 weeks

• Follow-up detection

  through study completion, an average of 1 year

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

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.

Other: Treatment group protocol

Control group

SHAM COMPARATOR

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.

Other: Control group protocol

Interventions

Treatment group protocol 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.

Treatment group

Control group protocol 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.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Wuhan No.1 Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator
• Edwatz Medical Research Institude: collaborator
• Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine: collaborator

Study Sites (1)

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

Wuhan, Hubei, 027, China

RECRUITING

Study Officials

• Dongmei Huang, doctor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Huang, doctor

CONTACT

13971578190; hdmjcr@qq.com

Hanwang Zhang, doctor

CONTACT

13386151967; hwzhang605@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Integrated Traditional Chinese and Western Medicine Tongji hospital Affiliation: Huazhong University of Science and Technology

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 22, 2021
• Study Start: September 9, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: January, 2026, for 1 year
• Access Criteria: only for research

Locations

CN (1)