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Trial registered on ANZCTR


Registration number
ACTRN12611000899943
Ethics application status
Approved
Date submitted
20/08/2011
Date registered
23/08/2011
Date last updated
23/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Auricular acupressure improves implantation rate of in vitro fertilization
Scientific title
Auricular acupressure improves implantation rate of the women undergoing in vitro fertilization
Secondary ID [1] 262853 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
implantation rate in in vitro fertilization 270591 0
anxiety 270632 0
Condition category
Condition code
Reproductive Health and Childbirth 270763 270763 0 0
Fertility including in vitro fertilisation
Mental Health 270802 270802 0 0
Anxiety
Alternative and Complementary Medicine 270803 270803 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Auricular acupressure (AA)
Shenmen (TF4, located at the bifurcation of the crura of antihelix), Endocrine (CO18, located at the bottom part of the incisura intertragica), and Internal Genitals (TF2, located at the middle point of the anterior portion of the triangular fossa) were selected as the auricular acupoints . Shenmen (TF4) functions to relieve anxiety. Endocrine (CO18) and Internal Genitals (TF2) improve functions of the endocrine system and regulate functions of the female reproductive system. After the above acupoints were sterilized with 75% alcohol, AA was performed by using acupressure seeds named Semen vaccariae. The seed was kept in place by a piece of opaque adhesive patch and fixed onto the acupoint selected. The subjects were asked to press the acupoints four times a day (08:00, 12:00, 16:00 and 20:00 h respectively) with 15 min each time by themselves. The strength should make the local auricle congestive, flushed, hot and ache. The AA was conducted on the two ears simultaneously. The AA treatment consisted of 6 days (from 12:00 h of the last day of TVOR to 20:00 h of the next day of ET).
Intervention code [1] 269226 0
Treatment: Other
Comparator / control treatment
Sham AA
Triple Energizer (CO17, located in the cavum conchae), Stomach (CO4, located at the commissure of superior concha and inferio concha, just below the disappearance of the crus of the helix) and Large Intestine (CO7, located at the inner 1/3 of the crus of the helix, lying at the lower portion of the superior concha) were selected as the “sham” auricular acupoints. All the three acupoints have not been documented to relieve anxiety, improve functions of the endocrine system or regulate functions of the female reproductive system. All the manipulation and process were exactly the same as the AA group above.
Control group
Placebo

Outcomes
Primary outcome [1] 279458 0
The levels of state anxiety, preoperative anxiety (including anesthesia related anxiety and surgery related anxiety) and the need-for-information were rated with State Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Timepoint [1] 279458 0
on the morning of the last day of trans-vaginal oocyte retrieval and on the morning of the day of embryo transfer
Secondary outcome [1] 287689 0
Data of clinical pregnancy rate (defined as the presence of at least one gestational sac or fetal heartbeat, confirmed by trans-vaginal ultrasound) for all the women were obtained from the medical records.
Timepoint [1] 287689 0
42 days after the embryo transfer
Secondary outcome [2] 287759 0
Data of implantation rate (defined as the number of gestational sacs per number of transferred oocytes) for all the women were obtained from the medical records.
Timepoint [2] 287759 0
42 days after the embryo transfer

Eligibility
Key inclusion criteria
The women were healthy women with regular menstrual cycles and normal sex hormone levels. No structural abnormalities of uterus and ovaries were found by vaginal ultrasound or laparoscopy. None of the women had received any assisted reproductive technology (ART) therapy before.
Minimum age
23 Years
Maximum age
38 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We excluded all the patients who were not fluent in Chinese, the patients with neurologic or psychiatric disorders, the patients who were taking any tranquillizer, acupressure or acupuncture therapy, patients with an ear deformity, or the patients with a history of smoking or drinking.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3792 0
China
State/province [1] 3792 0

Funding & Sponsors
Funding source category [1] 269707 0
Hospital
Name [1] 269707 0
Women's Hospital, School of Medicine, Zhejiang University
Address [1] 269707 0
No.1 on Xueshi Road, Hangzhou 310006
Country [1] 269707 0
China
Primary sponsor type
Hospital
Name
Women’s Hospital, School of Medicine, Zhejiang University
Address
No.1 on Xueshi Road, Hangzhou 310006
Country
China
Secondary sponsor category [1] 268746 0
None
Name [1] 268746 0
Address [1] 268746 0
Country [1] 268746 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To explore whether AA can relieve anxiety during the period from trans-vaginal oocyte retrieval (TVOR) to the embryo transfer (ET) in in vitro fertilization (IVF) treatment and improve clinical pregnancy rate (CPR) and implantation rate (IR) of IVF.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33029 0
Address 33029 0
Country 33029 0
Phone 33029 0
Fax 33029 0
Email 33029 0
Contact person for public queries
Name 16276 0
Fan QU
Address 16276 0
Women's Hospital, School of Medicine, Zhejiang University, No.1 on Xueshi Road, Hangzhou 310006
Country 16276 0
China
Phone 16276 0
+86-571-13429119143
Fax 16276 0
Email 16276 0
qufan43@yahoo.com.cn
Contact person for scientific queries
Name 7204 0
Fan QU
Address 7204 0
Women's Hospital, School of Medicine, Zhejiang University, No.1 on Xueshi Road, Hangzhou 310006
Country 7204 0
China
Phone 7204 0
+86-571-13429119143
Fax 7204 0
Email 7204 0
qufan43@yahoo.com.cn

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary