Prevalence of Subclinical Hypothyroidism in Women With Unexplained Infertility and the Effect of Thyroxin on Pregnancy Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 主要终点
- Pregnancy
研究概览
简要总结
Subclinical hypothyroidism(SCH) is the elevated thyroid stimulating hormone (TSH) with normal free Thyroxine levels and it is a mild or compensated form of primary hypothyroidism. It has been suggested that SCH is more prevalent in infertile women (especially in women with ovulatory disorders.Various rates of SCH was reported in infertile women in different populations
详细描述
Despite well-established recommendations on screening and treatment of overt hypothyroid in infertile women, there is a controversy regard the treatment of SCH in infertile women .
There are few published data on the prevalence of SCH and the outcome of treatment of SCH in infertile women, many were conducted during IVF cycles . Moreover there are inconsistent results in these studies being authors advised to treat SCH before IVF and some other articles find out no any benefit regarding treatment with Thyroxine in SCH
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unexplained infertility
- •TSH more than 2.5 and normal T3,T4 levels
- •Negative for Anti-thyroid antibodies
排除标准
- •current history of overt hypo or hyperthyroidism
- •recurrent pregnancy loss
- •women having franked causes for infertility like tubal blockage, pelvic inflammatory disease, endometriosis , ,uterine factor
- •Ovarian dysfunction or decreased ovarian reserve
- •abnormal seminal fluid analysis or male factor
研究组 & 干预措施
Sub clinical hypothyroid women
Levothyroxine sodium(Euthyrox 50µg and 25 µg MerckSerono) treatment was initiated and the women were followed in a combined clinic of endocrinologist and Gynecologist.
2.5 µg of Thyroxine daily was prescribed to women with TSH more than 2.5 mIU/L. Women with TSH more than 4mIU/L were given 50 µg daily . When pregnancy was confirmed Thyroxine was continued till 13 weeks gestation .
干预措施: Thyroxine (Drug)
结局指标
主要结局
Pregnancy
时间窗: 2 years
Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood
次要结局
- Miscarriage rate(13 weeks)
研究者
Ariana Jawad
Assistant Professor
Hawler Medical University