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Thyroxin in Subclinical Hypothyroidism

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ClinicalTrials.gov Identifier: NCT03712683
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Ariana Jawad, Hawler Medical University

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 Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
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 : September 1, 2016
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


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 Name: Euthyrox




Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 2 years ]
    Pregnancy was confirmed using human chorionic gonadotropin hormone (hCG) estimation from blood


Secondary Outcome Measures :
  1. Miscarriage rate [ Time Frame: 13 weeks ]
    viability and growth of embryos were confirmed by ultrasound



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712683


Sponsors and Collaborators
Hawler Medical University
Investigators
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Principal Investigator: Ariana Kh. Jawad, CABOG Hawler Medical University

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Responsible Party: Ariana Jawad, Assistant Professor, Hawler Medical University
ClinicalTrials.gov Identifier: NCT03712683     History of Changes
Other Study ID Numbers: HawlerMU2
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data of the research can be applied on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ariana Jawad, Hawler Medical University:
Unexplained Infertility, pregnancy rate,hypothyroidism

Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases