Thyroxin in Subclinical Hypothyroidism

Pregnancy Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712683
• Other study ID #: HawlerMU2
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: October 2018
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothyroidism
• Pregnancy Loss
• Sub Clinical Hypothyroidism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood	2 years
Secondary	Miscarriage rate	viability and growth of embryos were confirmed by ultrasound	13 weeks