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Thyroxin in Subclinical Hypothyroidism

Primary Purpose

Sub Clinical Hypothyroidism, Pregnancy Loss

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Thyroxine

About this trial

This is an interventional screening trial for Sub Clinical Hypothyroidism focused on measuring Unexplained Infertility, pregnancy rate,hypothyroidism

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sub clinical hypothyroid women

Arm 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 .

Outcomes

Primary Outcome Measures

Pregnancy

Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood

Secondary Outcome Measures

Miscarriage rate

viability and growth of embryos were confirmed by ultrasound

Full Information

NCT ID

NCT03712683

First Posted

October 17, 2018

Last Updated

October 25, 2018

Sponsor

Hawler Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03712683

Brief Title

Thyroxin in Subclinical Hypothyroidism

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2016 (Actual)

Primary Completion Date

July 1, 2017 (Actual)

Study Completion Date

July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sub Clinical Hypothyroidism, Pregnancy Loss

Keywords

Unexplained Infertility, pregnancy rate,hypothyroidism

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sub clinical hypothyroid women

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Thyroxine

Other Intervention Name(s)

Euthyrox

Intervention Description

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

Primary Outcome Measure Information:

Title

Pregnancy

Description

Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Miscarriage rate

Description

viability and growth of embryos were confirmed by ultrasound

Time Frame

13 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ariana Kh. Jawad, CABOG

Organizational Affiliation

Hawler Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data of the research can be applied on request

Learn more about this trial

Thyroxin in Subclinical Hypothyroidism

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