Thyroxin in Subclinical Hypothyroidism

Sponsor

Hawler Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT03712683

Collaborator

(none)

168

Enrollment

Arm

Actual Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Sub Clinical Hypothyroidism Pregnancy Loss	Drug: Thyroxine	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

168 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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 .	Drug: Thyroxine Thyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed Other Names: Euthyrox

Arm

Intervention/Treatment

Experimental: 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 .

Drug: Thyroxine

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

Other Names:

Euthyrox

Outcome Measures

Primary Outcome Measures

Pregnancy [2 years]
Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood

Secondary Outcome Measures

Miscarriage rate [13 weeks]
viability and growth of embryos were confirmed by ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hawler Medical University

Investigators

Principal Investigator: Ariana Kh. Jawad, CABOG, Hawler Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ariana Jawad, Assistant Professor, Hawler Medical University

ClinicalTrials.gov Identifier:

NCT03712683

Other Study ID Numbers:

HawlerMU2

First Posted:

Oct 19, 2018

Last Update Posted:

Oct 29, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ariana Jawad, Assistant Professor, Hawler Medical University

Unexplained Infertility, pregnancy rate,hypothyroidism

Additional relevant MeSH terms:

Hypothyroidism

Study Results

No Results Posted as of Oct 29, 2018