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

Decreased Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566210
• Other study ID #: S266
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: September 2022
• Source: Huazhong University of Science and Technology
• Contact: Cuihong Zheng, Professor
• Phone: 86-27-83663275
• Email: chzheng[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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,?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.

Related Conditions & MeSH terms

• Decreased Ovarian Reserve

Intervention

Device:
• acupuncture
acupuncture
• Sham acupuncture
Sham acupuncture

Locations

Country	Name	City	State
China	Tongji Hospital,Tongji medical college,HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AFC	Antral follicle count	on the 3rd day of menstruation
Secondary	Blood levels of FSH, LH, E2 and AMH on the 3rd day of menstruation		on the 3rd day of menstruation
Secondary	ß-HCG positive pregnancy rate		Two weeks after ET or when menstruation expired for natural pregnancy
Secondary	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
Secondary	Live birth rate		Gestation greater than 24 weeks and birth as a live fetus