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

NCT06641440 | Completed Phase 4

• 1 other identifier: CH-06-18
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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 their livebirth rate. The patients were treated with prednisone plus levothyroxine in the study group, whereas in the control group the women were treated only with levothyroxine. The patients were treated at least three months before to try again to remain pregnant in case of RPL or to undergo to another embryo transfer with a single blastocyst in case of RIF. The patients during treatment and during the eventual pregnancy will followed up with beta-HCG, anti-thyroid antibodies and TSH levels, as well as ultrasound scan to evaluate the embryo growth and its wellbeing. A statistical analysis will be performed to determine the levels of significance for the parameters evaluated.

Conditions

Recurrent Pregnancy Loss, Not Pregnant; Recurrent Implantation Failure

Keywords

antithyroid antibodies; RPL; RIF; embryotoxicity test; predisone treatment; levothyroxine

Outcome Measures

Primary Outcomes (1)

• livebirth rate

  number of babyis born divided the number become pregnant

  all the study time 5 yeard time frame

Secondary Outcomes (3)

• pregnancy rate

  all the study time 5 yeard time frame

• abortion rate

  all the study time 5 yeard time frame

• the negativization rate of antithyroid antibodies

  all the study time 5 yeard time frame

Study Arms (2)

prednisone plus levothyroxine

EXPERIMENTAL

25 mg of predisone plus 75 microgram levothyroxine daily for 3 months

Drug: Prednisone

levothyroxine only

ACTIVE COMPARATOR

75 micrograms of levothyroxine only daily for three months

Drug: Prednisone

Interventions

Prednisone DRUG

patients will be treated for three months in the two groups with the two different protocols for three months both

Also known as: levothyroxine

levothyroxine only; prednisone plus levothyroxine

Eligibility Criteria

• Age: 20 Years - 39 Years
• Gender Eligibility Details: only women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Endocrinology and Reproductive Medicine, Italy: lead

Study Sites (2)

CERM-Hungaria IVF Center

Rome, RM, 00153, Italy

Location

Cerm-Hungaria

Rome, 00153, Italy

Location

MeSH Terms

Interventions

Prednisone; Thyroxine

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Daniela A Marconi, MD

  Centre for Endocrinology and Reproductive Medicine, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: 25 mg prednisone plus 75 microgram levothyroxine daily 75 micrograms levothyroxine daily

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2018
• Primary Completion: December 30, 2023
• Study Completion: October 10, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)