- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07462754
Effect of Fire-Needle Combined With Regular Acupuncture on Pregnancy Outcome in Patients With Recurrent Implantation Failure Undergoing In Vitro Fertilization
This study aims to evaluate whether fire-needle combined with regular acupuncture improves pregnancy outcomes in patients with recurrent implantation failure (RIF), compared to no or regular acupuncture.
A retrospective cohort study was conducted at a university-affiliated hospital. One hundred RIF patients undergoing embryo transfer between July 2024 and June 2025 were assigned to three groups: a non-acupuncture group, a regular acupuncture group, and a fire needle combination group (receiving both fire needle and regular acupuncture).
Key outcome measures, including the β-hCG positive rate, clinical pregnancy rate (CPR), and miscarriage rate (MR), were compared among the three groups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1)18 ≤age ≤40 years; (2) ≥2 previous failures of high-quality embryo transfer without clinical pregnancy
Exclusion Criteria:
- (1) preimplantation genetic testing cycles; (2) use of donor oocytes; (3) missing key data on treatment or outcome
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: non-acupuncture group
|
no acupuncture
|
|
Experimental: regular acupuncture group
|
Regular acupuncture
|
|
Experimental: fire needle combination group
|
fire needle combination group (receiving both fire needle and regular acupuncture)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
β-hCG-positive pregnancy
Time Frame: 1 year
|
Test for hCG in the blood day 14 post-transfer
|
1 year
|
|
Clinical pregnancy
Time Frame: 1 year
|
ultrasonographic detection of an intrauterine gestational sac following embryo transfer
|
1 year
|
|
Miscarriage
Time Frame: 1 year
|
defined as spontaneous pregnancy loss occurring after ultrasound-confirmed clinical pregnancy
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TJ-IRB202503020
- 81874388 and 82274308 (Other Grant/Funding Number: National Natural Science Foundation of China)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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