ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Fertility including in vitro fertilisation

Alternative and Complementary Medicine

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]

Treatment: Other

Comparator / control treatment

Lifestyle modification only

Control group

Active

Outcomes

Primary outcome [1]

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]

After 3 month of intervention

Primary outcome [2]

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]

After 3 month of intervention. BBT charts & record of menstruation are completed monthly and collected at final interview after 3 months.

Secondary outcome [1]

Time from study entry to conception. Conception demonstrated by self-report of blood test.

Timepoint [1]

After 3 month of intervention

Secondary outcome [2]

Clinical pregnancy demonstrated by blood test at six weeks of pregnancy by self-report.

Timepoint [2]

Reported after 3 month of intervention

Secondary outcome [3]

Quality of life changes as measured by Measure Yourself medical Outcomes Profile(MYMOP) at three months

Timepoint [3]

After 3 month of intervention

Secondary outcome [4]

Lifestyle change demonstrated by incidence and compliance with smoking, exercise, diet and eating patterns at 3 months. Self report at final interview.

Timepoint [4]

After 3 month of intervention

Secondary outcome [5]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

2560

Recruitment postcode(s) [2]

2000

Funding & Sponsors

Funding source category [1]

University

Name [1]

UNiversity of Western Sydney

Address [1]

Locked Bag 1797
Penrith South DC 1797 NSW

Country [1]

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]

Other

Name [1]

National Intitute of Complementary Medicine

Address [1]

c/o University of Western Sydney
Campbelltown Campus
Locked Bag 1797
Penrith South DC 1797 NSW

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UWS Human Research Ethics Committee

Ethics committee address [1]

University of Western Sydney
Locked Bag 1797
Penrith South 1797 NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/10/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Suzanne Cochrane

Address

Centre for Complementary Medicine Research
Building 5
Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith South DC 1797 NSW

Country

Australia

Phone

+ 61 408510151 /+61 2 46203485

Fax

+61 2 46203291

[email protected]

Contact person for scientific queries

Name

Suzanne Cochrane

Address

Centre for Complementary Medicine Research
Building 5
Campbelltown Campus
University of Western Sydney
Locked Bag 1797
Penrith South DC 1797 NSW

Country

Australia

Phone

+61 2 46203485/+ 61 408510151

Fax

+61 2 46203291

[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

Source	Title	Year of Publication	DOI
Embase	Prior to Conception: The Role of an Acupuncture Protocol in Improving Women's Reproductive Functioning Assessed by a Pilot Pragmatic Randomised Controlled Trial.	2016	https://dx.doi.org/10.1155/2016/3587569

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically