Effect of Acupuncture on the Success Rate in Patients With Recurrent Implantation Failure
A Multicenter Randomized Controlled Trial Evaluating the Effect of Acupuncture on the Success Rate in Patients With Recurrent Implantation Failure
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
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
-
Contact:
- Pu Zhou
- Phone Number: +8602783662379
- Email: tongjihlunli@163.com
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo group
nonpenetrating placebo needles
|
nonpenetrating placebo needles
|
|
Experimental: acupuncture group
indwelling intradermal needles
|
indwelling intradermal needles
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical pregnancy
Time Frame: 1 year
|
defined as ultrasonographic detection of an intrauterine gestational sac following embryo transfer
|
1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
β-hCG-positive pregnancy
Time Frame: 1 year
|
defined as serum β-hCG concentration >10 mIU/mL on day 14 post-transfer
|
1 year
|
|
Endometrial thickness
Time Frame: 1 year
|
Endometrial thickness on Transformation Day
|
1 year
|
|
endometrial blood flow
Time Frame: 1 year
|
1 year
|
|
|
anxiety assessment
Time Frame: 1 year
|
1 year
|
|
|
depression assessment
Time Frame: 1 year
|
1 year
|
|
|
sleep quality assessment
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- TJ-IRB202510016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.