evothyroxine for recurrent miscarriage

Conditions: Thyroid autoimmunity is associated with recurrent miscarriage and preterm birth. Thyroid autoimmunity means there is a normal thyroid function, but presence of thyroid antibodies, thyroid peroxidase antibodies (TPO-Ab).
MedDRA version: 16.0Level: LLTClassification code 10027649Term: MiscarriageSystem Organ Class: 100000004868
MedDRA version: 16.0Level: LLTClassification code 10027650Term: Miscarriage of pregnancySystem Organ Class: 100000004868
MedDRA version: 16.0Level: LLTClassification code 10048437Term: Anti-thyroid antibodiesSystem Organ Class: 100000004848
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2011-001820-39-DK

Lead Sponsor: Academic medical centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 240

Inclusion Criteria

1.Women with unexplained RM and thyroid autoimmunity. Recurrent miscarriage is defined as two or more miscarriages. TPOAb positivity is defined as a TPO titre higher then 100 kU/ltr or two times higher then 60 kU/ltr.
2.Age 18 - 42 years at randomisation
3.Willing and able to give informed consent (IC).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Antiphospholipid syndrome (lupus anticoagulant and/ or anticardiolipin antibodies [IgG or IgM])
2. Other auto-immune conditions
3.Previous enrolment in the trial
4. Abnormal TSH levels
5. Contraindications to levothyroxine use:
Adrenal or pituitary disorders, untreated
Thyreotoxicosis, untreated
Acute cardiac arrest
Acute pancreatitis
Acute myocarditis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess improvement in live birth rate after levothyroxine supplementation. <br>Primary outcome measure: live birth rate.;Secondary Objective: To evaluate the effect of levothyroxine supplementation on adverse pregnancy outcomes, like preterm birth. <br>Secondary outcome measures: miscarriage rate, any adverse pregnancy outcomes. ;Primary end point(s): Live birth rate;Timepoint(s) of evaluation of this end point: Evaluation will be at the end of the pregnancy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Miscarriage rate, preterm birth or any other adverse pregnancy outcomes;Timepoint(s) of evaluation of this end point: Evaluation will be at the end of the pregnancy