Thyroxin in Subclinical Hypothyroidism

Hawler Medical University

Status: Completed

Conditions: Pregnancy Loss; Sub Clinical Hypothyroidism

Treatments: Drug: Thyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT03712683

HawlerMU2

Details and patient eligibility

About

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

Full 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

Enrollment: 168 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Unexplained infertility
2. TSH more than 2.5 and normal T3,T4 levels
3. Negative for Anti-thyroid antibodies

Exclusion criteria

1. current history of overt hypo or hyperthyroidism
2. recurrent pregnancy loss
3. women having franked causes for infertility like tubal blockage, pelvic inflammatory disease, endometriosis , ,uterine factor
4. Ovarian dysfunction or decreased ovarian reserve
5. abnormal seminal fluid analysis or male factor

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

Sub clinical hypothyroid women

Experimental group

Description:

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 .

Treatment:

Drug: Thyroxine