Clinical trial NCT05566210: Effects of Acupuncture on Ovarian Function and Pregnancy Outcomes in Women With Decreased Ovarian Reserve
Official title: Effects of Acupuncture on Ovarian Reserve Function and Pregnancy Outcomes in Women With Decreased Ovarian Reserve: a Multicenter Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decreased Ovarian Reserve
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AFC
timeFrame: on the 3rd day of menstruation
Secondary outcomes:
measure: Blood levels of FSH, LH, E2 and AMH on the 3rd day of menstruation
timeFrame: on the 3rd day of menstruation
measure: β-HCG positive pregnancy rate
timeFrame: Two weeks after ET or when menstruation expired for natural pregnancy
measure: Clinical pregnancy rate
timeFrame: 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
measure: Live birth rate
timeFrame: Gestation greater than 24 weeks and birth as a live fetus
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital,Tongji medical college,HUST
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Cuihong Zheng, Professor
role: PRINCIPAL_INVESTIGATOR
References: