NCT05566210

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

December 2, 2022

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

September 30, 2022

Last Update Submit

December 1, 2022

Conditions

Decreased Ovarian Reserve

Outcome Measures

Primary Outcomes (1)

  • AFC

    Antral follicle count

    on the 3rd day of menstruation

Secondary Outcomes (4)

  • 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

Study Arms (2)

Acupuncture group

ACTIVE COMPARATOR

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

Sham acupuncture group

PLACEBO COMPARATOR

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

acupunctureDEVICE

acupuncture

Acupuncture group
Sham acupunctureDEVICE

Sham acupuncture

Sham acupuncture group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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；
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Cuihong Zheng, Professor

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cuihong Zheng, Professor

CONTACT

86-27-83663275chzheng@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 4, 2022

Study Start

October 1, 2022

Primary Completion

September 30, 2024

Study Completion

August 30, 2025

Last Updated

December 2, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)