NCT07462754

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 10, 2026

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

February 25, 2026

Last Update Submit

March 8, 2026

Conditions

Implantation Failure

Outcome Measures

Primary Outcomes (3)

  • β-hCG-positive pregnancy

    Test for hCG in the blood day 14 post-transfer

    1 year

  • Clinical pregnancy

    ultrasonographic detection of an intrauterine gestational sac following embryo transfer

    1 year

  • Miscarriage

    defined as spontaneous pregnancy loss occurring after ultrasound-confirmed clinical pregnancy

    1 year

Study Arms (3)

non-acupuncture group

OTHER
Other: no acupuncture

regular acupuncture group

EXPERIMENTAL
Device: regular acupuncture

fire needle combination group

EXPERIMENTAL
Device: Fire needle combination group

Interventions

no acupunctureOTHER

no acupuncture

non-acupuncture group
regular acupunctureDEVICE

Regular acupuncture

regular acupuncture group
Fire needle combination groupDEVICE

fire needle combination group (receiving both fire needle and regular acupuncture)

fire needle combination group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1)18 ≤age ≤40 years; (2) ≥2 previous failures of high-quality embryo transfer without clinical pregnancy

You may not qualify if:

  • (1) preimplantation genetic testing cycles; (2) use of donor oocytes; (3) missing key data on treatment or outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 10, 2026

Study Start

July 1, 2024

Primary Completion

June 30, 2025

Study Completion

October 31, 2025

Last Updated

March 10, 2026

Record last verified: 2024-06

Locations

CN(1)