Acupuncture's effects on ovarian function and pregnancy outcomes in women with low ovarian reserve

Effects of Acupuncture on Ovarian Reserve Function and Pregnancy Outcomes in Women With Decreased Ovarian Reserve: a Multicenter Randomized Controlled Clinical Study

This study tests if acupuncture can help improve ovarian function and pregnancy success for women with low ovarian reserve who are trying to conceive.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05566210 on ClinicalTrials.gov

What this trial studies

This multicenter trial investigates the impact of acupuncture on ovarian function and pregnancy outcomes in women with decreased ovarian reserve. Participants are randomly assigned to either an acupuncture group or a sham acupuncture group after providing informed consent. The study aims to assess whether acupuncture can improve fertility outcomes in women undergoing IVF or attempting to conceive naturally. The trial is conducted across three centers in China, focusing on women aged 18 to 40 with specific hormonal and ovarian response criteria.

Who should consider this trial

Good fit: Ideal candidates are infertile women aged 18 to 40 with decreased ovarian reserve as indicated by specific hormonal levels and previous low ovarian response.

Not a fit: Patients with severe uterine abnormalities or uncontrolled endocrine diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive treatment option to enhance fertility in women with decreased ovarian reserve.

How similar studies have performed: While acupuncture has been explored in fertility treatments, this specific approach targeting decreased ovarian reserve is relatively novel and has not been extensively tested.

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.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital,Tongji medical college,HUST — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Cuihong Zheng, Professor — Huazhong University of Science and Technology
• Study coordinator: Cuihong Zheng, Professor

Conditions Decreased Ovarian Reserve