Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000015448
Ethics application status
Approved
Date submitted
19/12/2006
Date registered
9/01/2007
Date last updated
16/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Does acupuncture improve the endometrium for women undergoing an embryo transfer: a pilot randomised controlled trial
Scientific title
Does acupuncture improve the endometrium for women undergoing an embryo transfer: a pilot randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility, women undergoing an embryo transfer 1516 0
Condition category
Condition code
Reproductive Health and Childbirth 1614 1614 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture versus standard care.

Women allocated to the acupuncture group will receive three treatments of acupuncture. The first treatment will be administered two days prior to egg harvest and two treatments will be administered on the day of the embryo transfer immediately before and after transfer. The first acupuncture treatment will be administered based on the traditional Chinese medicine diagnosis. The treatments administered at embryo transfer will be following the protocol used by Smith and colleagues in previous research. This protocol is as follows
Study group : Treatment with acupuncture
Acupuncture points to be used will be selected according to the individual Chinese medicine diagnosis, and at the time of the first treatment. The second treatment will be administered 25 minutes prior to embryo transfer. Classical acupuncture points pericardium 6 (PC6), Spleen 8 (SP8), Liver 3 (LR3), Stomach 29 (ST29), and Conception vessel (CV4) will be used. Auricular acupuncture points Shenmen, Zhigong, Neifenmi and Naodian will also be used. The third treatment will be administered 25 minutes after embryo transfer using acupuncture points Stomach 36 (ST36), Spleen 6 (SP6), and Spleen 10 (SP10). Auricular points Shenmen, Zhigong, Neifenmi and Naodian will be also be needled. Seirin acupuncture needles will be inserted to tissue level and stimulated manually to elicit the Deqi response. Needles will be retained for 25 minutes in each treatment.

Study group 2: Standard care
The standard treatment protocols for In Vitro Fertilisation and embryo transfer will be followed.

All women will have an ultrasound to assess the thickness of the endometrium and pattern at day 9. Further ultrasound measurements will be made at the time of the embryo transfer and one week following egg harvest (day 16). Routine bloods will be taken prior to egg harvest and additional blood will be taken one week following egg harvest.

The trial will run for six months.
Intervention code [1] 1486 0
Treatment: Other
Comparator / control treatment
Women allocated to the control group will receive the usual care provided at the reproductive medicine unit.
Control group
Active

Outcomes
Primary outcome [1] 2226 0
Change in endometrium thickness
Timepoint [1] 2226 0
At baseline and pattern at embryo transfer (day three after egg harvest) and one week following egg harvest.
Secondary outcome [1] 3881 0
Duration of hormonal stimulation during the In Vitro Fertilisation cycle
Timepoint [1] 3881 0
From day 9 through to seven days post egg harvest.

Eligibility
Key inclusion criteria
Undergoing (fresh natural and stimulated cycle) embryo transfer at day 3.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing a frozen cycle.

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)
Concealment by sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor, clinician undertaking the ultrasound and data analyst will be blind. Subjects and the therapist will not be blind to group allocation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1760 0
Charities/Societies/Foundations
Name [1] 1760 0
Australian Acupuncture and Chinese Medicine Association
Country [1] 1760 0
Australia
Primary sponsor type
University
Name
Discipline Obstetrics and Gynaecology, School of Paediatrics and Reproductive Health, University of Adelaide
Address
The University of Adelaide
North Terrace
Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 1560 0
None
Name [1] 1560 0
Nil
Address [1] 1560 0
Country [1] 1560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3284 0
Children, Youth and Women's Health Service
Ethics committee address [1] 3284 0
Ethics committee country [1] 3284 0
Australia
Date submitted for ethics approval [1] 3284 0
Approval date [1] 3284 0
20/11/2006
Ethics approval number [1] 3284 0
REC 1869/9/09

Summary
Brief summary
The aim of this study is to examine whether the use of acupuncture improves the characteristics of the endometrium associated with implantation and pregnancy.

Women will be randomised to receive acupuncture or standard care (control group). Women will be randomised at day 9 subject to the result of ultrasound and blood test.

The endometrium will be assessed by vaginal ultrasound and the endometrium thickness and pattern recorded. The ultrasound will be performed by a fertility specialists blind to the study group (routine scan) at day nine to assess timing for egg retrieval. Further ultrasound measurements will be undertaken at the time of Embryo Transfer (ET) and an extra ultrasound undertaken one week following egg retrieval.
Routine bloods will be taken prior to egg retrieval and additional blood will be taken on day seven following egg retrieval. Routine measurement of plasma oestradiol and progesterone will be taken.

Study group : Treatment with acupuncture
Acupuncture points to be used will be selected according to the individual Traditional Chinese Medicine (TCM) diagnosis, and at the time of the first treatment. The second treatment will be administered 25 minutes prior to embryo transfer. Classical acupuncture points pericardium 6 (PC6), Spleen 8 (SP8), Liver 3 (LR3), Stomach 29 (ST29), and Conception vessel (CV4) will be used. Auricular acupuncture points Shenmen, Zhigong, Neifenmi and Naodian will also be used. The third treatment will be administered 25 minutes after embryo transfer using acupuncture points Stomach 36 (ST36), Spleen 6 (SP6), and Spleen 10 (SP10). Auricular points Shenmen, Zhigong, Neifenmi and Naodian will be also be needled. Seirin acupuncture needles will be inserted to tissue level and stimulated manually to elicit the Deqi response. Needles will be retained for 25 minutes in each treatment.

Study group 2: Standard care
The standard treatment protocols for In Vitro Fertilization (IVF) and embryo transfer will be followed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27420 0
Address 27420 0
Country 27420 0
Phone 27420 0
Fax 27420 0
Email 27420 0
Contact person for public queries
Name 10675 0
Dr Caroline Smith
Address 10675 0
Centre for Complementary medicine Research, The University of Western Sydney
Country 10675 0
Australia
Phone 10675 0
02 4620 3777
Fax 10675 0
Email 10675 0
[email protected]
Contact person for scientific queries
Name 1603 0
Dr Caroline Smith
Address 1603 0
Centre for Complementary medicine Research, The University of Western Sydney
Country 1603 0
Australia
Phone 1603 0
02 4620 3777
Fax 1603 0
Email 1603 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.