Clinical trial NCT05804149: Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
Official title: Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Hypothyroidism
Acupuncture
Irregular Menstruation
PCO
Keywords: primary hypothyroidism
acupuncture
low caloric diet
infertile women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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,

* Each patient in the study group was instructed about the beneficial effect of the Acupuncture.
* Each woman in the study group assumed supine position for the points (DU20, GB20, ST9, LI4, RN6, RN4, SP9, ST36, SP6, KI3, LR2). and prone position for DU14, BL15, BL20, BL23, DU4 with uncovered treatment area, which was cleaned with alcohol and hair was removed.

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.

Eligibility criteria: Inclusion Criteria:

* Sixty PCOS women will be evaluated for presence of hirsutism, acne, irregular menses. They will be diagnosed for presence of cysts by Ultrasonography apparatus.
* They will complain from primary hypothyroidism. Their thyroid-stimulating hormone (TSH) will be \>4.0mu/l and free tetraiodothyronine (FT4) will be \<0.8ng/dl.
* Their luteinizing hormone / follicle-stimulating hormone (LH/FSH) ratio will be \<1.
* Their age will range from 20-35 years old.
* Their body mass index (BMI) will be \> 25 kg/m2 and \< 39.9 kg/m2.

Exclusion Criteria:

* History of previous neurological disorders, previous thyroidectomy, and surgical removal of uterus.
* Presence of hemorrhage, carcinoma, metal implants and using of immune suppressant drugs.
* Presence of endometriosis, uterine fibroids, primary ovary insufficiency, fallopian tube damage or blockage, pelvic adhesion, autoimmune disorders, implantation failure, and infections.

Primary outcomes:
measure: Thyroid hormones (TSH). (mu/l)
timeFrame: change from TSH at 4 months.
measure: Thyroid hormones (FT4). (ng/dl)
timeFrame: change from FT4 at 4 months.
measure: BMI (kg/m2).
timeFrame: change from BMI at 4 months.
measure: reproductive hormones including LH(IU/L)
timeFrame: change LH at 4 months.
measure: FSH (mIU/mL)
timeFrame: change from FSH at 4 months.
measure: Health-Related Quality-of-Life (PCOS Questionnaire) (score from 26:182 units on scale)
timeFrame: change from PCOS Questionnaire at 4 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Eman Sedky
state: Maadi
Study officials:
References: