Clinical trial NCT06223178: Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve
Official title: Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diminished Ovarian Reserve
Keywords: Diminished Ovarian Reserve
Acupoint
Thumb-tack Needle
Randomized Controlled Trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Hangzhou Hospital of Traditional Chinese Medicine
First posted: 2024-01-25
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes of serum follicle-stimulating hormone (FSH) level
timeFrame: baseline，week 4, week 12，week 20(week 8 in follow-up)
Secondary outcomes:
measure: changes of 1.Serum Anti-Müllerian Hormone (AMH) level
timeFrame: baseline，week 12, week 20(week 8 in follow-up)
measure: temperature of sensitized acupoint
timeFrame: baseline，week 4, week 12，week 20(week 8 in follow-up)
measure: pain threshold of sensitized acupoint
timeFrame: baseline，week 4, week 12，week 20(week 8 in follow-up)
measure: the modified Kupperman Index(KI)
timeFrame: baseline，week 4, week 12，week 20(week 8 in follow-up)
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: baseline，week 4, week 12，week 20(week 8 in follow-up)
measure: Self-rating Depression Scale (SDS)
timeFrame: baseline，week 4, week 12，week 20(week 8 in follow-up)
measure: Psychological constitution of traditional Chinese medicine(TCM）
timeFrame: baseline，week 4, week 12，week 20(week 8 in follow-up)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xiaomei Shao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: