Thyroxin in Subclinical Hypothyroidism

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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

Official Title
-----------------
Prevalence of Subclinical Hypothyroidism in Women With Unexplained Infertility and the Effect of Thyroxin on Pregnancy Rate

Conditions
-----------------
Sub Clinical Hypothyroidism, Pregnancy Loss

Intervention / Treatment
-----------------
* Drug: Thyroxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unexplained infertility TSH more than 2.5 and normal T3,T4 levels Negative for Anti-thyroid antibodies Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sub clinical hypothyroid women<br>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 . | Drug: Thyroxine<br>* Thyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed<br>* Other names: Euthyrox;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Miscarriage rate | viability and growth of embryos were confirmed by ultrasound | 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unexplained Infertility, pregnancy rate,hypothyroidism