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

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Decreased Ovarian Reserve

Treatments: Device: acupuncture; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05566210

S266

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

180 participants in 2 patient groups, including a placebo group

Acupuncture group

Active Comparator group

Description:

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)

Treatment:

Device: acupuncture

Sham acupuncture group

Placebo Comparator group

Description:

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)

Treatment:

Device: Sham acupuncture