NCT06223178

Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve

Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve: Study Protocol for a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Xiaomei Shao · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diminished Ovarian Reserve

Interventions

Type	Name	Description
DEVICE	thumb-tack needle	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.
DEVICE	sham thumb-tack needle	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.
OTHER	Basic gynecological treatment	Gynecological health care guidance will be provided as patients needed.

Timeline

• Start date: 2023-11-03
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-01-25
• Last updated: 2024-01-30

Locations

1 site across 1 country: China