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Completed

NCT Number: NCT03712683

Thyroxin in Subclinical Hypothyroidism

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

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Key information

Conditions

Sub Clinical Hypothyroidism Pregnancy Loss

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroxine

Drug

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

Other names: Euthyrox

Primary outcomes

  1. Pregnancy

    Time frame: 2 years

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

Secondary outcomes

  1. Miscarriage rate

    Time frame: 13 weeks

    viability and growth of embryos were confirmed by ultrasound

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2018
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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