None listed
Conditions
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.
Interventions
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)
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.
Sponsors
University of Western Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 44 Years
Healthy volunteers
No
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.
Outcome results
None listed