NCT03964779Unknown不适用
Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- prevalence of thyroid dysfunction among infertile women
研究概览
简要总结
The study population will be divided into three groups:
- Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
- Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
- Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group.
. All women will be subjected to:
- Informed consent
- Full history taking, including age, duration of infertility and whether primary or secondary
- General and pelvix examination
- Trans-vaginal ultrasonography
- Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
- Determination of ovulatory status
- Determination of of tubal patency
- Determination of presence of male factor
- Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels
详细描述
The study population will be divided into three groups:
- Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
- Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
- Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group.
. All women will be subjected to:
- Informed consent
- Full history taking, including age, duration of infertility and whether primary or secondary
- General and pelvix examination
- Trans-vaginal ultrasonography
- Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
- Determination of ovulatory status (by previous documented history of induction of ovulation OR previous ultrasonography OR previous estimation midluteal serum progesterone, etc ...)
- Determination of of tubal patency (by previous hysterosalpingiography or laparoscopy)
- Determination of presence of male factor (by seminal fluid analysis)
- Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •- Age: 18 - 38 years
- •Infertile women whether due to functional, anatomical, male factors OR unexplained OR combined factors
排除标准
- •- Age: below 18 and above 38 years
- •Patients with autoimmune diseases (such as lupus and rheumatoid arthritis)
- •Acute illness that require hospitalization
- •Patients on the following medications: steroids, dopamine, iodine, amiodarone, lithium, donperidone, thyroid hormone, and phenytoin.
- •Patients who work at night.
结局指标
主要结局
prevalence of thyroid dysfunction among infertile women
时间窗: through study completion, an average of 6 months
prevalence of thyroid dysfunction (clinical or subclinical, hypothyroidism or hyperthyroidism) among infertile women
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
professor
Cairo University
研究点 (1)
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