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

October 14, 2024 updated by: Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy

Prednisone Plus Levothyroxine Versus Only Levothyroxine to Treat RPL and RIF Women With Thyroisd Autoimmunity Positive to Embryotoxicity Test.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 at the same time these women were also positive to the embryotoxicity test (more than 80% of patients positive for antithyroid antibodies were also positive for the embryotoxicity test). Consequently we decided to conduct a controlled study on the treatment of these patients, all euthyroid, with corticosteroids, predisone, plus levothyroxine comparing them to similar patients treated with levothyroxine only. The study will be conducted in patients with unexplained RPL (3 or more pregnancies lost before the 20th week, without any recognized cause for RPL, such as uterine anomalies, parental chromosomal abnormalities, genetic or acquired thrombophilia) or with unexplained RIF (patients who failed to become pregnant after the transfer of at least 4 good quality blastocysts, without recognized cause for RIF according to the scientific literature). The patients will be randomly assigned, by a computer generated sequency to one of the two arms of the study, the study group where the patients included will be treated with 25 mg of Prednisone plus 75 micrograms of Levothyroxine for at lest three months, and the women included in the control will be treated with 75 micrograms of Levothyroxine for at lest three months, similarly to other group.Afterwards, women will be tested for thyroid antibodies (anti-thyroglobulin and anti-thyroid peroxidase) and for embryotoxicity test. Patients will be able to plan a pregnancy after this in case of RPL or for an embryo transfer with a previously cryopreserved blasocyst.. The sample size calculation for an increase of 100% of the anticipated success rate (livebirth rate as primary end point) in the control group of 30% in bothh type of patients with RPL and RIF showed the needs of 42 patients for arm to have an alfa of <0.05 and a power of 0.8. The primary outcome will be the livebirth rate, and secondary outcome will be pregnancy rate for RIF, abortion rate and negativization rate of the thyroid antibodies and embryotoxicity test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00153
        • Cerm-Hungaria
    • RM
      • Rome, RM, Italy, 00153
        • CERM-Hungaria IVF Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: prednisone plus levothyroxine
25 mg of predisone plus 75 microgram levothyroxine daily for 3 months
Drug: Prednisone
patients will be treated for three months in the two groups with the two different protocols for three months both
Other Names:
  • levothyroxine
Active Comparator: levothyroxine only
75 micrograms of levothyroxine only daily for three months
Drug: Prednisone
patients will be treated for three months in the two groups with the two different protocols for three months both
Other Names:
  • levothyroxine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
livebirth rate
Time Frame: all the study time 5 yeard time frame
number of babyis born divided the number become pregnant
all the study time 5 yeard time frame

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: all the study time 5 yeard time frame
the number of women become pregnant divided for all women included in the study
all the study time 5 yeard time frame
abortion rate
Time Frame: all the study time 5 yeard time frame
the number of abortion divided the number of pregnancy
all the study time 5 yeard time frame
the negativization rate of antithyroid antibodies
Time Frame: all the study time 5 yeard time frame
number of patients positive for thyroid antibodies who become negative percent
all the study time 5 yeard time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Endocrinology and Reproductive Medicine, Italy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Daniela A Marconi, MD, Centre for Endocrinology and Reproductive Medicine, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CH-06-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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