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Fertility acupuncture clinical trial

Not Applicable
Recruiting
Conditions
Fertility/infertility
Reproductive Health and Childbirth - Fertility including in vitro fertilisation
Alternative and Complementary Medicine - Other alternative and complementary medicine
Registration Number
ACTRN12610000631000
Lead Sponsor
niversity of Western Sydney
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
56
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.

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

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.[After 3 month of intervention. BBT charts & record of menstruation are completed monthly and collected at final interview after 3 months.];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.[After 3 month of intervention]
Secondary Outcome Measures
NameTimeMethod
Time from study entry to conception. Conception demonstrated by self-report of blood test.[After 3 month of intervention];Clinical pregnancy demonstrated by blood test at six weeks of pregnancy by self-report.[Reported after 3 month of intervention];Quality of life changes as measured by Measure Yourself medical Outcomes Profile(MYMOP) at three months[After 3 month of intervention];Lifestyle change demonstrated by incidence and compliance with smoking, exercise, diet and eating patterns at 3 months. Self report at final interview.[After 3 month of intervention];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.[After 3 month of intervention]
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