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

Study Overview
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Brief Summary
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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.

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

Conditions
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Decreased Ovarian Reserve

Intervention / Treatment
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* Device: acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile women older than 18 years and younger than 40 years to undergo fresh IVF or self-pregnant; AMH<1.1 ng/ml； total AFC< 7； 10 U/L<FSH< 25IU/L,或FSH/LH>2.6； 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）； 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: 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); 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; Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.; Untreated hydrosalpinx; Body mass index (BMI) higher than 28 kg/m; The male or female chromosome abnormality; People with previous history of acupuncture sickness; Those who have previously participated in the study or are currently receiving acupuncture treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture group<br>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) | Device: acupuncture<br>* acupuncture<br>|
| Placebo Comparator: Sham acupuncture group<br>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) | Device: Sham acupuncture<br>* Sham acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AFC | Antral follicle count | on the 3rd day of menstruation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |