Effects of Acupuncture on Ovarian Function and Pregnancy Outcomes in Women With Decreased Ovarian Reserve

NCT ID: NCT05566210

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-08-30

Brief Summary

The randomized, placebo-controlled multicenter trial is conducted in three centers in China. After screening and obtaining the signed informed consent, the participants are randomly divided into two groups: acupuncture group and sham acupuncture group.

Conditions

Decreased Ovarian Reserve

Study Design

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

Study Groups

Acupuncture group

Acupuncture was performed 2-3 times a week for 30 minutes each time for 3 months, starting from the 5th day of menstruation (spontaneous menstruation or drug withdrawal hemorrhaging menstruation)

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: DEVICE

acupuncture

Sham acupuncture group

Sham acupuncture was performed 2-3 times a week for 30 minutes each time for 3 months, starting from the 5th day of menstruation (spontaneous menstruation or drug withdrawal hemorrhaging menstruation)

Group Type: PLACEBO_COMPARATOR

Sham acupuncture

Intervention Type: DEVICE

Sham acupuncture

Interventions

acupuncture

acupuncture

Intervention Type: DEVICE

Sham acupuncture

Sham acupuncture

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Infertile women older than 18 years and younger than 40 years to undergo fresh IVF or self-pregnant;

2. AMH<1.1 ng/ml；

3. total AFC< 7；

4. 10 U/L<FSH< 25IU/L,或FSH/LH>2.6；

5. had a history of low ovarian response once, and the number of eggs obtained in IVF was less than 3 （at least two of the 2）3）4）5 ）items are required）；

6. Willing to accept randomized grouping, treatment arrangement and follow-up, and signing informed consent.

Exclusion Criteria

Patients who met any of the following conditions were not included:

1. Severe abnormality of uterine cavity caused by adenomyosis, uterine fibroids, endometrial polyps, tuberculosis of the reproductive system, endometritis, abnormal endometrial thickness (HCG day of the previous IVF cycle is less than 7mm or greater than 14mm);

2. Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;

3. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;

4. Untreated hydrosalpinx;

5. Body mass index (BMI) higher than 28 kg/m;

6. The male or female chromosome abnormality;

7. People with previous history of acupuncture sickness;

8. Those who have previously participated in the study or are currently receiving acupuncture treatment.

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

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Cui Hong Zheng

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cuihong Zheng, Professor

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology

Locations

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cuihong Zheng, Professor

Role: CONTACT

chzheng@tjh.tjmu.edu.cn

86-27-83663275

Facility Contacts

Cuihong Zheng, Professor

Role: primary

chzheng@tjh.tjmu.edu.cn

86-27-83663275

Other Identifiers

S266

Identifier Type: -

Identifier Source: org_study_id