Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve

Xiaomei Shao

Status: Enrolling

Conditions: Diminished Ovarian Reserve

Treatments: Device: sham thumb-tack needle; Device: thumb-tack needle; Other: Basic gynecological treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06223178

2023ZX010-DOR

Details and patient eligibility

About

Diminished Ovarian Reserve (DOR) is characterized as an important cause of infertility. Acupuncture has been extensively used to treat female infertility. This study was conducted to investigate the efficacy of thumb-tack needle，as a new special type of acupuncture and long-lasting treatment modality,in the treatment of DOR.

Full description

There will be a multi-center, randomized, sham-controlled trial. 106 patients will be randomly assigned into thumb-tack needle acupuncture or sham-acupuncture in 1:1 ratio. All the patents will achieve 12 sessions of verum or sham treatments in 20 weeks(12 weeks for treatment and 8 weeks for follow-up). Patients, outcome assessors and statisticians are masked from group assignment. The study is aim to evaluate the efficacy of thumb-tack needle for DOR.

Enrollment: 106 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old ≤ age < 40 years old, female;

• Clinical diagnosis of Diminished Ovarian Reserve: meet both items in twice tests with an interval of at least 4 weeks(tested between 2rd to 4th day of menstrual cycle):

  1. 10 IU/L < FSH < 20 IU/L,
  2. Anti-Müllerian hormone(AMH) < 1.1ng/mL.

• without any mind disease, willing to participate in the study and sign the informed consent.

• without any other treatment.

Exclusion criteria

• Low or no response to exogenous gonadotropins, or with congenital anomalies in the development of the reproductive tract；
• Pregnant or breastfeeding;
• Abnormal body temperatures at the moment;
• Psychopath, alcoholic, Patient with severe depression, history of substance abuse and severe primary diseases of cardiovascular, liver, kidney and hematopoietic system;
• Currently enrolled in other clinical trials or refuse to cooperate with the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Thumb-tack needle acupuncture

Experimental group

Description:

53 Patients in this group will achieve 24 sessions treatment of thumb-tack needle in 12 consecutive weeks. Treatment will be operated by trained acupuncturists.

Treatment:

Device: thumb-tack needle

Other: Basic gynecological treatment

Sham acupuncture group

Sham Comparator group

Description:

A sham thumb-tack needle, which has no difference in appearance with the verum thumb-tack needle but is lack of needle, are used for 53 patient in this group. 24 sessions of treatment will be performed in 12 consecutive weeks. Treatment will be operated by trained acupuncturists.

Treatment:

Other: Basic gynecological treatment

Device: sham thumb-tack needle