Thyroxin in Subclinical Hypothyroidism

Sponsor
Hawler Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03712683
Collaborator
(none)
168
Enrollment
1
Arm
10
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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    1. Pregnancy [2 years]

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

    Secondary Outcome Measures

    1. 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:
    No
    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

    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:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ariana Jawad, Assistant Professor, Hawler Medical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 29, 2018