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the goal of this randomize clinical trial is to compare in 60 infertile women with hypothyroidism. selected from national Nutritional institute out clinic. the main question it aims to answer is:
• There an effect of acupuncture and low caloric diet on primary hypothyroidism and irregular menstruation in infertile women.
all participants were received• thyroxine tablets (levothyroxine) • a low caloric diet regime.
researchers compared study group (30 infertile women with hypothyroidism) to see the effect of acupuncture sections on hypothyroidism.
Each woman was instructed carefully about the assessment and treatment procedures and a consent form has been signed by each woman before starting of this study,
Acupuncture was applied on a room temperature of 37. Fine sterile needles used with a size 0.25x25mm. They were inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles were used in the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | Each patient in the study group will be instructed about the beneficial effect of the acupuncture.
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| control group | Other | Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine Each woman in both groups will follow a low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. The regime will start with 1200 Kcal for the first month and 1100 for the second month then 900 Kcal for the third month until reach 800 Kcal in fourth month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | study group take acupuncture Acupuncture was applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thyroid hormones (TSH). (mu/l) | 60 participants with hypothyroidism assessed by blood analysis for thyroid hormones to measure percentage of improvement of hypothyroidism. ELISA plate reader used to measure thyroid hormones including (TSH) measured by mu/l, before starting and after the end of the study course. | change from TSH at 4 months. |
| Thyroid hormones (FT4). (ng/dl) | 60 participants with hypothyroidism assessed by blood analysis for thyroid hormones to measure percentage of improvement of hypothyroidism. ELISA plate reader used to measure thyroid hormones including (FT4) measured by ng/dl, before starting and after the end of the study course. | change from FT4 at 4 months. |
| BMI (kg/m2). | 60 infertile women with hypothyroidism assessed by Weight-Height scale. to measure weight (kg) and height (cm) to calculate BMI at starting and after the end of the study course. BMI will be calculated according to the formula: BMI=Weight/Height square (kg/m2). | change from BMI at 4 months. |
| reproductive hormones including LH(IU/L) | 60 participants with hypothyroidism assessed by blood analysis for reproductive hormones to measure percentage of improvement of infertility (PCOS). ELISA plate reader used to measure (LH) measured by (IU/L) before starting and after the end of the study course. | change LH at 4 months. |
| FSH (mIU/mL) | 60 participants with hypothyroidism assessed by blood analysis for reproductive hormones to measure percentage of improvement of infertility (PCOS). ELISA plate reader used to measure (FSH) measured by (mIU/mL), before starting and after the end of the study course. | change from FSH at 4 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eman Sedky | Cairo | Maadi | 002 | Egypt |
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| ID | Term |
|---|---|
| D007037 | Hypothyroidism |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D013974 | Thyroxine |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
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Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine Acupuncture will be applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months.
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| Thyroxine | Drug | Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine |
|
|
| low caloric diet | Dietary Supplement | Each woman in both groups will follow a low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. The regime will start with 1200 Kcal for the first month and 1100 for the second month then 900 Kcal for the third month until reach 800 Kcal in fourth month. |
|
| Health-Related Quality-of-Life (PCOS Questionnaire) (score from 26:182 units on scale) | 60 participants infertile women assessed by Health-Related Quality-of-Life Questionnaire (PCOSQ) to asses health and health related quality of life issues including emotion, body hair, weight, infertility problems, and menstrual problems for each woman in both control and study groups before starting and after the end of the study course. Score from 26:182 units on scale as questionnaire consists of 26 questions, foreach question, there is seven rating options. heigh score means more improvement, while low score means less improvement | change from PCOS Questionnaire at 4 months. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |