Thyroxin in Subclinical Hypothyroidism

NCT03712683 | Completed DMC

• 1 other identifier: HawlerMU2
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sub Clinical Hypothyroidism; Pregnancy Loss

Keywords

Unexplained Infertility, pregnancy rate,hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Pregnancy

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

  2 years

Secondary Outcomes (1)

• Miscarriage rate

  13 weeks

Study Arms (1)

Sub clinical hypothyroid women

EXPERIMENTAL

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

Thyroxine DRUG

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

Also known as: Euthyrox

Sub clinical hypothyroid women

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Unexplained infertility
• TSH more than 2.5 and normal T3,T4 levels
• Negative for Anti-thyroid antibodies

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawler Medical University: lead

MeSH Terms

Interventions

Thyroxine

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ariana Kh. Jawad, CABOG

  Hawler Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share