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

Not Applicable

Recruiting

• Conditions: Decreased Ovarian Reserve
• Interventions: Device: acupuncture; Device: Sham acupuncture

• Registration Number: NCT05566210
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Study Start: 2022-10-01
• Study First Posted: 2022-10-04
• Last Update Submitted: 2022-12-01
• Last Update Posted: 2022-12-02
• Primary Completion: 2024-09-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture group	acupuncture	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)
Sham acupuncture group	Sham acupuncture	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)

Primary Outcome Measures

Name	Time	Method
AFC	on the 3rd day of menstruation	Antral follicle count

Secondary Outcome Measures

Name	Time	Method
Blood levels of FSH, LH, E2 and AMH on the 3rd day of menstruation	on the 3rd day of menstruation
β-HCG positive pregnancy rate	Two weeks after ET or when menstruation expired for natural pregnancy
Clinical pregnancy rate	4 weeks after ET or natural pregnancy: B ultrasonography was used to observe whether there were pregnant sac and cardiac tube pulsation in uterine cavity
Live birth rate	Gestation greater than 24 weeks and birth as a live fetus

Trial Locations

Locations (1)

Tongji Hospital,Tongji medical college,HUST; 🇨🇳 Wuhan, Hubei, China