Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve

NCT06223178 | Unknown

• 1 other identifier: 2023ZX010-DOR
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diminished Ovarian Reserve

Keywords

Diminished Ovarian Reserve; Acupoint; Thumb-tack Needle; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• changes of serum follicle-stimulating hormone (FSH) level

  The increasing of serum follicle-stimulating hormone（FSH） is one of the main symptoms of Diminished Ovarian Reserve. The normal value of FSH is 1.37-9.9 U/L in follicular phase, and higher the FSH value, the worse ovarian function. Patients in this study will be asked to take the serum FSH text between day2 to day4 of menstrual period in whole observation. Patients with amenorrhea take every 28 days as a supposed menstrual cycle instead.

  baseline，week 4, week 12，week 20(week 8 in follow-up)

Secondary Outcomes (7)

• changes of 1.Serum Anti-Müllerian Hormone (AMH) level

  baseline，week 12, week 20(week 8 in follow-up)

• temperature of sensitized acupoint

  baseline，week 4, week 12，week 20(week 8 in follow-up)

• pain threshold of sensitized acupoint

  baseline，week 4, week 12，week 20(week 8 in follow-up)

• the modified Kupperman Index(KI)

  baseline，week 4, week 12，week 20(week 8 in follow-up)

• Self-Rating Anxiety Scale (SAS)

  baseline，week 4, week 12，week 20(week 8 in follow-up)

Study Arms (2)

Thumb-tack needle acupuncture

EXPERIMENTAL

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.

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

Sham acupuncture group

SHAM COMPARATOR

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.

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

Interventions

thumb-tack needle DEVICE

Sterilizing skin and avoiding vessels, the thumb-tack needle are directly stock to the surface of acupoints by a band-aid, kneading and pressing for 5 minutes. The thumb-tack needle will be embedded in the skin and keep staying for 72 hours. Patients will be taught to press them 3 to 4 times per day. As tolerated by them, each pressing will lasts 1 minutes with an interval of about 4 hours.

Thumb-tack needle acupuncture

sham thumb-tack needle DEVICE

Sterilizing skin and avoiding vessels, the sham thumb-tack needle are directly stock to the surface of acupoints by a band-aid, kneading and pressing for 5 minutes. The sham device will be embedded in the skin and keep staying for 72 hours. Patients will be taught to press them 3 to 4 times per day. As tolerated by them, each pressing will lasts 1 minutes with an interval of about 4 hours.

Sham acupuncture group

Basic gynecological treatment OTHER

Gynecological health care guidance will be provided as patients needed.

Sham acupuncture group; Thumb-tack needle acupuncture

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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):
• IU/L \< FSH \< 20 IU/L,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiaomei Shao: lead
• Hangzhou Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hangzhou, Zhejiang, China

RECRUITING

Study Officials

• Xiaomei Shao, Ph.D

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Shao, Ph.D

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Hanyu Liu

CONTACT

+8617857314691; 912782196@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 25, 2024
• Study Start: November 3, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CN (1)