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CompletedNCT03712683Updated Oct 29, 2018

Thyroxin in Subclinical Hypothyroidism

An interventional study of Thyroxine in Sub Clinical Hypothyroidism and Pregnancy Loss, sponsored by Hawler Medical University. Completed. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2018-10-29.

Sponsored by Hawler Medical University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2016, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Not applicable
Ages
18 Years to 42 Years
Sex
Female
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Study 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

Read the 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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Conditions studied

  • Sub Clinical Hypothyroidism
  • Pregnancy Loss

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Keywords

  • Unexplained Infertility, pregnancy rate,hypothyroidism
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In context

Hypothyroidism

247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.

This study's enrollment of 168 is above the median of 78 across 128 interventional studies indexed under Hypothyroidism.

Browse Hypothyroidism studies →

Lead sponsor

Hawler Medical University is the lead sponsor of 56 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • 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

Interventions

  • DrugThyroxine

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

    Also known as: Euthyrox

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What researchers measure

Primary outcomes

  1. Pregnancy

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

    Time frame: 2 years

Secondary outcomes

  1. Miscarriage rate

    viability and growth of embryos were confirmed by ultrasound

    Time frame: 13 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — Data of the research can be applied on request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03712683
Lead sponsor
Hawler Medical University
Responsible party
Ariana Jawad (Assistant Professor, Hawler Medical University) — Principal investigator
First posted
Oct 19, 2018
Start date
Sep 1, 2016
Primary completion
Jul 1, 2017
Completion
Jul 1, 2017
Last update
Oct 29, 2018

Study contacts

Ariana Kh. Jawad, CABOG
principal investigator · Hawler Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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