Effects of Different Acupuncture Techniques 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 Contact
Study Contact
- Name: Pu Zhou
- Phone Number: +8602783662379
- Email: tongjihlunli@163.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Hospital,Tongji medical college,HUST
-
Contact:
- Cuihong Zheng, professor
- Phone Number: 86-27-83663275
- Email: chzheng@tjh.tjmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meets the criteria for RIF diagnosis (≥ 3 instances of unsuccessful transfer of high-quality embryos).
- Age: < 40 years.
- Planning for a cycle involving the transfer of frozen-thawed embryos (FET).
- Possession of a transplantable frozen blastocyst (≥3BB).
- 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).
- Those with significant abnormalities in immunity or coagulation.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: placebo acupuncture group
nonpenetrating placebo needles
|
nonpenetrating placebo needles
|
|
Experimental: acupuncture group 1
indwelling intradermal needles
|
indwelling intradermal needles
|
|
Experimental: acupuncture group 2
combining fire needle and regular acupuncture
|
combining fire needle and regular acupuncture
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical pregnancy
Time Frame: 2 years
|
defined as ultrasonographic detection of an intrauterine gestational sac following embryo transfer
|
2 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
β-hCG-positive pregnancy
Time Frame: 2 years
|
defined as serum β-hCG concentration >10 mIU/mL on day 14 post-transfer
|
2 years
|
|
live birth
Time Frame: 3 years
|
defined as the delivery of 1 or more living infants at greater than 20 weeks' gestation or birth weight of at least 400 g
|
3 years
|
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-IRB202605092
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
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