Treatment With Prednisone of Women With RPL or RIF Positive to Antithyroid Antibodies and Embryotoxicity Test

Phase 4

Completed

• Conditions: Recurrent Pregnancy Loss, Not Pregnant; Recurrent Implantation Failure
• Interventions: Drug: Prednisone

• Registration Number: NCT06641440
• Lead Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy

Brief Summary

In Reproductive Medicine there is a unresolved question, whether thyroid autoimmunity may promote infertility, embryo demise and miscarriage. A study was conducted in order to evaluate which treatment is more effective in women with recurrent pregnancy loss (RPL) or recurrent implantation failure (RIF) and positivity to anti-thyroid antibodies to improve the...

Detailed Description

This controlled study follows our observational study where we evaluated the frequency of positivity of patients with RPL or RIF to antithyroid antibodies and at the same time their positivity to the embryotoxicity test. In the observational study we documented how a high percentage of these women were positive for antithyroid antibodies, more than 20%, and ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2023-12-30
• Status Verified: 2024-10
• Study Completion: 2024-10-10
• Study First Submitted: 2024-10-12
• Study First Submitted QC: 2024-10-12
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• euthyroid women
• with RPL
• with RIF, positivity to anti-thyroid antibodies (anti thyreoglobulin and/or anti thyroid peroxidase),

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Exclusion Criteria

• No autoimmune diseases (SLE, RA),
• no diabetes,
• no hearth diseases,
• no egg donation cases,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prednisone plus levothyroxine	Prednisone	25 mg of predisone plus 75 microgram levothyroxine daily for 3 months
levothyroxine only	Prednisone	75 micrograms of levothyroxine only daily for three months

Primary Outcome Measures

Name	Time	Method
livebirth rate	all the study time 5 yeard time frame	number of babyis born divided the number become pregnant

Secondary Outcome Measures

Name	Time	Method
abortion rate	all the study time 5 yeard time frame	the number of abortion divided the number of pregnancy
the negativization rate of antithyroid antibodies	all the study time 5 yeard time frame	number of patients positive for thyroid antibodies who become negative percent
pregnancy rate	all the study time 5 yeard time frame	the number of women become pregnant divided for all women included in the study

Trial Locations

Locations (2)

CERM-Hungaria IVF Center; 🇮🇹 Rome, RM, Italy

Cerm-Hungaria; 🇮🇹 Rome, Italy