Fertility acupuncture clinical trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2010
INTERVENTION: 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. CONDITION: Fertility/infertility PRIMARY OUTCOME: 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. 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. SECONDARY OUTCOME: Clinical pregnancy demonstrated by blood test at six weeks of pregnancy by self‐report. 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. Lifestyle change demonstrated by incidence and compliance with smoking, exercise, diet and eating patterns at 3 months. Self report at final interview. Quality of life changes as measured by Measure Yourself medical Outcomes Profile(MYMOP) at three months Time from study entry to conception. Conception demonstrated by self‐report of blood test. 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.
Epistemonikos ID: 9016b1adcd53af9435e2489221495225cf4fb0c5
First added on: Aug 22, 2024