Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000631000
Ethics application status
Approved
Date submitted
9/12/2009
Date registered
2/08/2010
Date last updated
2/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fertility acupuncture clinical trial
Scientific title
Fertility acupuncture clinical trial [FACT]: a pragmatic randomised controlled trial into the effectiveness of peri-conceptual acupuncture on female reproduction in addition to active lifestyle intervention in women having difficulty conceiving: a pilot study
Secondary ID [1] 252353 0
nil
Universal Trial Number (UTN)
U1111-1112-3052
Trial acronym
FACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility/infertility 252068 0
Condition category
Condition code
Reproductive Health and Childbirth 252269 252269 0 0
Fertility including in vitro fertilisation
Alternative and Complementary Medicine 258023 258023 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture + lifestyle modification. 1. 9 Acupuncture sessions of 1 hour duration, once per week within a 12 week period; manualised points chosen according to time of cycle, Traditional Chinese Medicine(TCM) & biomedical diagnosis & presenting symptoms; disposable stainless steel needles applied to a depth and with manipulation according to standard acupuncture text; deqi sensation required. 2. Lifestyle modification includes applying the Commonwealth Scientific & Research Organisation (CSIRO) diet & adjusting exercise daily - increase if not including aerobic, decrease if over-exercising as deemed appropriate at initial interview.
Intervention code [1] 241461 0
Treatment: Other
Comparator / control treatment
Lifestyle modification only
Control group
Active

Outcomes
Primary outcome [1] 253139 0
Increased awareness of fertility, referring to a set of practices used to determine the fertile and infertile phases of a woman's menstrual cycle and lifestyle choices known to enhance fertility at three months. Self-report questionnaire plus adherence to basal body temperature (BBT) charting.
Timepoint [1] 253139 0
After 3 month of intervention
Primary outcome [2] 253140 0
normalisation of the menstrual cycle, such as improved regularity of menstrual cycle documented by basal body temperature (BBT) chart and diary measured at end of 1st, 2nd and 3rd month of treatment, reduced pain, reduced incidence of clotting.
Timepoint [2] 253140 0
After 3 month of intervention. BBT charts & record of menstruation are completed monthly and collected at final interview after 3 months.
Secondary outcome [1] 262029 0
Time from study entry to conception. Conception demonstrated by self-report of blood test.
Timepoint [1] 262029 0
After 3 month of intervention
Secondary outcome [2] 262030 0
Clinical pregnancy demonstrated by blood test at six weeks of pregnancy by self-report.
Timepoint [2] 262030 0
Reported after 3 month of intervention
Secondary outcome [3] 262031 0
Quality of life changes as measured by Measure Yourself medical Outcomes Profile(MYMOP) at three months
Timepoint [3] 262031 0
After 3 month of intervention
Secondary outcome [4] 262032 0
Lifestyle change demonstrated by incidence and compliance with smoking, exercise, diet and eating patterns at 3 months. Self report at final interview.
Timepoint [4] 262032 0
After 3 month of intervention
Secondary outcome [5] 262033 0
Examination of the acceptability of the intervention and women's experience of the intervention at three months. 'Experience of Acupuncture' questionnaire & extended interviews of selected participants.
Timepoint [5] 262033 0
After 3 month of intervention

Eligibility
Key inclusion criteria
1. Women of reproductive age (18-44 years old);
2. Women with at least 12 months of trying to conceive (unprotected sex) without success (including miscarriage);
3. Women who are actively trying to conceive;
4. Women who have had a gynaecological diagnosis of the causes of their infertility or sub fertility;
5. Women not planning to use acupuncture during the trial intervention;
6. Able to attend for at least 7 of 9 sessions.
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-patent fallopian tubes evident on Hysterosalpingogram or HSG ;
2. absence of uterus;
3. primary anovulation; or
4. partner sperm defect indicated on semen analysis.

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)
Interested women will be interviewed and inclusion/exclusion criteria applied. If suitable for inclusion they will be randomised into active intervention or active control groups. Managed by CompleMED research staff independent of the project investigators. The random allocation will be sealed in opaque numbered envelopes held in sequential order and accessed by the acupuncturist from the top of the sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence will be computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
There will be no blinding of patient or acupuncturist. Data entry and analysis will be undertaken blind to group allocation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2169 0
2560
Recruitment postcode(s) [2] 2170 0
2000

Funding & Sponsors
Funding source category [1] 243930 0
University
Name [1] 243930 0
UNiversity of Western Sydney
Country [1] 243930 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797
Penrith South DC 1797
NSW
Country
Australia
Secondary sponsor category [1] 251287 0
Other
Name [1] 251287 0
National Intitute of Complementary Medicine
Address [1] 251287 0
c/o University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith South DC 1797 NSW
Country [1] 251287 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244042 0
UWS Human Research Ethics Committee
Ethics committee address [1] 244042 0
University of Western Sydney
Locked Bag 1797
Penrith South 1797 NSW
Ethics committee country [1] 244042 0
Australia
Date submitted for ethics approval [1] 244042 0
Approval date [1] 244042 0
23/10/2009
Ethics approval number [1] 244042 0
H7588

Summary
Brief summary
The study involves women who have had trouble falling pregnant. The study plans to offer women a course of either acupuncture treatment plus lifestyle modification or lifestyle modification only designed to improve menstrual regularity and improve the likelihood of pregnancy.

Women who are trying to have a baby without success will be asked to either undertake acupuncture treatments plus diet and exercise programs for 3 months or to adopt a diet and exercise program only. Both options are designed to increase fertility. Acupuncture will be offered from either Campbelltown or a city clinic and each woman receiving acupuncture is expected to attend weekly for 1 hour.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30425 0
Address 30425 0
Country 30425 0
Phone 30425 0
Fax 30425 0
Email 30425 0
Contact person for public queries
Name 13672 0
Suzanne Cochrane
Address 13672 0
Centre for Complementary Medicine Research
Building 5
Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith South DC 1797 NSW
Country 13672 0
Australia
Phone 13672 0
+ 61 408510151 /+61 2 46203485
Fax 13672 0
+61 2 46203291
Email 13672 0
[email protected]
Contact person for scientific queries
Name 4600 0
Suzanne Cochrane
Address 4600 0
Centre for Complementary Medicine Research
Building 5
Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith South DC 1797 NSW
Country 4600 0
Australia
Phone 4600 0
+61 2 46203485/+ 61 408510151
Fax 4600 0
+61 2 46203291
Email 4600 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
SourceTitleYear of PublicationDOI
EmbasePrior to Conception: The Role of an Acupuncture Protocol in Improving Women's Reproductive Functioning Assessed by a Pilot Pragmatic Randomised Controlled Trial.2016https://dx.doi.org/10.1155/2016/3587569
N.B. These documents automatically identified may not have been verified by the study sponsor.