Recurrent Pregnancy Loss, Not PregnantPhase 4NCT06641440
Treatment With Prednisone of Women With RPL or RIF Positive to Antithyroid Antibodies and Embryotoxicity Test
A Phase 4 study testing Prednisone in people with Recurrent Pregnancy Loss, Not Pregnant and Recurrent Implantation Failure, run by Centre for Endocrinology and Reproductive Medicine, Italy at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Not Pregnant, Recurrent Implantation Failure
- What is being tested?
- Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2018to 10 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- euthyroid women
- with RPL
- with RIF, positivity to anti-thyroid antibodies (anti thyreoglobulin and/or anti thyroid peroxidase),
Who cannot join
- No autoimmune diseases (SLE, RA),
- no diabetes,
- no hearth diseases,
- no egg donation cases,
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read 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 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.
- Being tested
- Prednisone
- Keywords
- antithyroid antibodies, RPL, RIF, embryotoxicity test, predisone treatment, levothyroxine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called levothyroxine
patients will be treated for three months in the two groups with the two different protocols for three months both
| Study group | Role | What they receive |
|---|---|---|
| prednisone plus levothyroxine | Experimental | 25 mg of predisone plus 75 microgram levothyroxine daily for 3 months Receives: Drug: Prednisone |
| levothyroxine only | Active comparator | 75 micrograms of levothyroxine only daily for three months Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
livebirth rate
number of babyis born divided the number become pregnant
Measured: all the study time 5 yeard time frame
Secondary outcomes (3)
pregnancy rate
the number of women become pregnant divided for all women included in the study
Measured: all the study time 5 yeard time frame
abortion rate
the number of abortion divided the number of pregnancy
Measured: all the study time 5 yeard time frame
the negativization rate of antithyroid antibodies
number of patients positive for thyroid antibodies who become negative percent
Measured: all the study time 5 yeard time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2018
- Primary completion30 Dec 2023
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy Loss, Not PregnantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 25 mg prednisone plus 75 microgram levothyroxine daily 75 micrograms levothyroxine daily
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy
- Investigators
- Daniela A Marconi, MD, Study chair, Centre for Endocrinology and Reproductive Medicine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641440
- Sponsor's protocol ID
- CH-06-18
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone Plus Levothyroxine Versus Only Levothyroxine to Treat RPL and RIF Women With Thyroisd Autoimmunity Positive to Embryotoxicity Test.
- ClinicalTrials.gov ID
- NCT06641440
- Acronym / sponsor ID
- CH-06-18
- Keywords
- antithyroid antibodies, RPL, RIF, embryotoxicity test, predisone treatment, levothyroxine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, ItalyResearch network
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 25 mg prednisone plus 75 microgram levothyroxine daily 75 micrograms levothyroxine daily
| Arm | Type | Receives |
|---|---|---|
| prednisone plus levothyroxine | Experimental | Drug: Prednisone25 mg of predisone plus 75 microgram levothyroxine daily for 3 months |
| levothyroxine only | Active comparator | Drug: Prednisone75 micrograms of levothyroxine only daily for three months |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- euthyroid women
- with RPL
- with RIF, positivity to anti-thyroid antibodies (anti thyreoglobulin and/or anti thyroid peroxidase),
Key exclusion criteria (4 listed)
- No autoimmune diseases (SLE, RA),
- no diabetes,
- no hearth diseases,
- no egg donation cases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: levothyroxinepatients will be treated for three months in the two groups with the two different protocols for three months both | Drug | levothyroxine only, prednisone plus levothyroxine |
Primary outcome
livebirth rate
Time frame: all the study time 5 yeard time frame
number of babyis born divided the number become pregnant
3 secondary outcomes
pregnancy rate
Time frame: all the study time 5 yeard time frame
abortion rate
Time frame: all the study time 5 yeard time frame
the negativization rate of antithyroid antibodies
Time frame: all the study time 5 yeard time frame
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela A Marconi, MD study chair
Centre for Endocrinology and Reproductive Medicine, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Recurrent Pregnancy Loss, Not Pregnant and Recurrent Implantation Failure, run by Centre for Endocrinology and Reproductive Medicine, Italy at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
livebirth rate (time frame: all the study time 5 yeard time frame). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.