Thyroxin in Subclinical Hypothyroidism

NCT ID: NCT03712683

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-07-01

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

Conditions

Sub Clinical Hypothyroidism; Pregnancy Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

Thyroxine

Intervention Type: DRUG

Thyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed

Interventions

Thyroxine

Thyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed

Intervention Type: DRUG

Other Intervention Names

Euthyrox

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ariana Jawad

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariana Kh. Jawad, CABOG

Role: PRINCIPAL_INVESTIGATOR

Hawler Medical University

Other Identifiers

HawlerMU2

Identifier Type: -

Identifier Source: org_study_id