Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women

NCT05804149 | Completed Phase 2

• 1 other identifier: No:P.T.REC/012/002825
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hypothyroidism; Acupuncture; Irregular Menstruation; PCO

Keywords

primary hypothyroidism; acupuncture; low caloric diet; infertile women

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

Study Arms (2)

study group

EXPERIMENTAL

Each patient in the study group will be instructed about the beneficial effect of the acupuncture. * Each woman in the study group will assume side lying position with uncovered treatment area, * 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 regime consisting of 1200 to 800Kcal/ day for 4 months. * Fine sterile needles will be used with a size 0.25x25mm. They will be inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles will be used in the treatment

Device: acupuncture; Drug: Thyroxine; Dietary Supplement: low caloric diet

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.

Drug: Thyroxine; Dietary Supplement: low caloric diet

Interventions

acupuncture DEVICE

study group take acupuncture Acupuncture was applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months.

study group

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

Also known as: levothyroxine

control group; study group

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.

control group; study group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Eman Sedky

Cairo, Maadi, 002, Egypt

Location

MeSH Terms

Conditions

Hypothyroidism; Menstruation Disturbances

Interventions

Acupuncture Therapy; Thyroxine; Caloric Restriction

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Diet Therapy; Nutrition Therapy; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: April 7, 2023
• Study Start: August 30, 2020
• Primary Completion: September 25, 2022
• Study Completion: February 12, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)