NCT07669623

Brief Summary

To conduct a multi-center, randomized, controlled clinical study aimed at formally evaluating the impact of different acupuncture methods on the success rate in patients with recurrent implantation failure

Trial Health

77
On Track

Trial Health Score

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

Enrollment
312

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress1%
Jul 2026Jun 2029

First Submitted

Initial submission to the registry

June 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

July 17, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

June 20, 2026

Last Update Submit

July 16, 2026

Conditions

Implantation Failure

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy

    defined as ultrasonographic detection of an intrauterine gestational sac following embryo transfer

    2 years

Secondary Outcomes (2)

  • β-hCG-positive pregnancy

    2 years

  • live birth

    3 years

Study Arms (3)

placebo acupuncture group

PLACEBO COMPARATOR

nonpenetrating placebo needles

Device: Placebo Group

acupuncture group 1

EXPERIMENTAL

indwelling intradermal needles

Device: acupuncture group 1

acupuncture group 2

EXPERIMENTAL

combining fire needle and regular acupuncture

Device: acupuncture group 2

Interventions

Placebo GroupDEVICE

nonpenetrating placebo needles

placebo acupuncture group
acupuncture group 1DEVICE

indwelling intradermal needles

acupuncture group 1
acupuncture group 2DEVICE

combining fire needle and regular acupuncture

acupuncture group 2

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets the criteria for RIF diagnosis (≥ 2 instances of unsuccessful transfer of high-quality embryos).
  • Age: 20 to 40 years old.
  • Planning for a cycle involving the transfer of frozen-thawed embryos (FET).
  • Possession of a transplantable D3 frozen embryo (≥6 cells) or a frozen blastocyst (≥3BC).
  • Estradiol-progesterone replacement therapy: endometrial thickness ≥ 7 mm within the period of endometrial transformation.

You may not qualify if:

  • Individuals planning to undergo preimplantation genetic diagnosis (PGD).
  • Recipients of egg donations.
  • Chromosomal abnormalities in either spouse or one partner (excluding chromosomal polymorphisms).
  • Patients with known embryo-related factors leading to implantation failure.
  • Abnormalities of the uterus that may affect implantation (including uterine malformations, uterine tuberculosis, submucosal myomas, severe uterine adhesions, severe uterine endometriosis, myomas with a diameter of ≥4 cm, and so on).
  • Abnormalities in immunity and blood coagulation
  • Recurrent spontaneous abortions (loss of a fetus before 28 weeks of gestation occurring twice or more).
  • Individuals with other endocrine disorders, such as thyroid disorders, hyperprolactinemia, insulin resistance, diabetes, and adrenal disorders, whose hormone levels have not been well-controlled over the past 3 months.
  • Individuals with untreated hydrosalpinx;
  • Individuals with a Body Mass Index (BMI) below 18 and above 25 kg/ m2.
  • Men with severe abnormalities in semen quality.
  • Individuals with a history of needle phobia.
  • Individuals who have previously participated in this study or received acupuncture treatment within the past three months;
  • Any other conditions deemed unsuitable for participation by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital,Tongji medical college,HUST

Wuhan, Hubei, 430030, China

RECRUITING

Central Study Contacts

Pu Zhou

CONTACT

+8602783662379tongjihlunli@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical professor, principal investigator

Study Record Dates

First Submitted

June 20, 2026

First Posted

June 25, 2026

Study Start

July 17, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)