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RecruitingNCT05566210Updated Dec 2, 2022

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

An interventional study of acupuncture and Sham acupuncture in Decreased Ovarian Reserve, sponsored by Huazhong University of Science and Technology. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-12-02.

Sponsored by Huazhong University of Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Oct 2022; still recruiting 4 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Decreased Ovarian Reserve
03

In context

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    Acupuncture group

    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

  • Placebo comparator
    Sham acupuncture group

    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

Interventions

  • Deviceacupuncture

    acupuncture

  • DeviceSham acupuncture

    Sham acupuncture

06

What researchers measure

Primary outcomes

  1. AFC

    Antral follicle count

    Time frame: on the 3rd day of menstruation

Secondary outcomes

  1. Blood levels of FSH, LH, E2 and AMH on the 3rd day of menstruation

    Time frame: on the 3rd day of menstruation

  2. β-HCG positive pregnancy rate

    Time frame: Two weeks after ET or when menstruation expired for natural pregnancy

  3. Clinical pregnancy rate

    Time frame: 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

  4. Live birth rate

    Time frame: Gestation greater than 24 weeks and birth as a live fetus

07

Study locations

1 of 1 sites recruiting
  • Tongji Hospital,Tongji medical college,HUST
    Wuhan, Hubei, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05566210
Lead sponsor
Huazhong University of Science and Technology
Responsible party
Cui Hong Zheng (Associate professor, Huazhong University of Science and Technology) — Principal investigator
First posted
Oct 4, 2022
Start date
Oct 1, 2022
Primary completion
Sep 30, 2024 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Dec 2, 2022

Study contacts

Cuihong Zheng, Professor
Contact
chzheng@tjh.tjmu.edu.cn
86-27-83663275
Cuihong Zheng, Professor
principal investigator · Huazhong University of Science and Technology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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