Thyroid DiseasesNCT04943146
An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity
An observational study of Thyroid Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
Thyroid autoimmunity(TAI) per se have adverse effect on pregnancy outcomes，and aspirin and prednisone were used frequently in antithyroid antibodies(ATA) positive infertile women in clinical practice, but the impact of these medicines is still controversial. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- Prednisone 10 MG+aspirin 100MG
- Type of treatment
- Pill or oral medicine
- How many people
- 402 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2021to Mar 2022
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Both TPOAb and TgAb in all the subjects were measured before ART procedure, and their thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L and also they all underwent first embryo transfer without previous IVF history.
Who may be able to join
- Both TPOAb and TgAb in all the subjects were measured before ART procedure
- Thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L
- Women underwent first embryo transfer without previous IVF history.
Who cannot join
- Abnormal thyroid function test
- Women with known autoimmune diseases or clinical presentations of autoimmune disorders
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
People's Hospital of Jinhua
Jinhua, Zhejiang
libo Zou, 13586988089, Zoulibo@163.com
- Recruiting
Ningbo Women and Children's Hospital
Ningbo, Zhejiang
limin Zhou, 13605883969, zhou.li.ming@163.com
About this study
Official title: An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity Undergoing In Vitro Fertilization
Thyroid autoimmunity(TAI) per se have adverse effect on pregnancy outcomes，and aspirin and prednisone were used frequently in antithyroid antibodies(ATA) positive infertile women in clinical practice, but the impact of these medicines is still controversial. Therefore, aim of the study was to investigate whether or not the treatment of prednisone in addition to aspirin was capable of improving reproductive outcomes in euthyroid infertile women.
Read the detailed description
A multicenter retrospective study performed during the period of 2017 to 2020 and euthyroid infertile women positive for anti-thyroperoxidase antibody (TPOAb) and/or thyroglobulin antibody (TgAb) alone with thyroid stimulating hormone 0.35-4.0mIU/L undergoing first in vitro fertilization and embryo transfer(IVF-ET) cycle were recruited in our study.Data analysis was performed using the Statistics Package for Social Sciences.In the end, the value of prednisone plus aspirin treatment was investigated to make a big contribution on clinical practice.
- Conditions
- Thyroid Diseases
- Being tested
- Prednisone 10 MG+aspirin 100MG
- Keywords
- Prednisolone, Assisted reproductive technology, Aspirin, thyroid diseases
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone 10 MG+aspirin 100MGDrug
Discontinue medication based on early pregnancy outcome
| Study group | Role | What they receive |
|---|---|---|
| control group | Not described | |
| P+A group | aspirin: tablet 100mg qd 2-5weeks prednisone: tablet 10mg qd 2-5weeks Receives: Drug: Prednisone 10 MG+aspirin 100MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Clinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac
Measured: 3 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Mar 2021
- Primary completionJun 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, People's Hospital of Jinhua
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943146
- Sponsor's protocol ID
- 2021-0062
- Status last verified
- Mar 2021
- First submitted
- 21 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: uncertainty
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity Undergoing In Vitro Fertilization
- ClinicalTrials.gov ID
- NCT04943146
- Acronym / sponsor ID
- 2021-0062
- Conditions
- Thyroid Diseases
- Keywords
- Prednisolone, Assisted reproductive technology, Aspirin, thyroid diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, People's Hospital of Jinhua
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 29 Jun 2021 (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.
Thyroid autoimmunity(TAI) per se have adverse effect on pregnancy outcomes，and aspirin and prednisone were used frequently in antithyroid antibodies(ATA) positive infertile women in clinical practice, but the impact of these medicines is still controversial. Therefore, aim of the study was to investigate whether or not the treatment of prednisone in addition to aspirin was capable of improving reproductive outcomes in euthyroid infertile women.
Detailed description
A multicenter retrospective study performed during the period of 2017 to 2020 and euthyroid infertile women positive for anti-thyroperoxidase antibody (TPOAb) and/or thyroglobulin antibody (TgAb) alone with thyroid stimulating hormone 0.35-4.0mIU/L undergoing first in vitro fertilization and embryo transfer(IVF-ET) cycle were recruited in our study.Data analysis was performed using the Statistics Package for Social Sciences.In the end, the value of prednisone plus aspirin treatment was investigated to make a big contribution on clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | – |
| P+A group | – | Drug: Prednisone 10 MG+aspirin 100MGaspirin: tablet 100mg qd 2-5weeks prednisone: tablet 10mg qd 2-5weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Both TPOAb and TgAb in all the subjects were measured before ART procedure, and their thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L and also they all underwent first embryo transfer without previous IVF history.
Key inclusion criteria (3 listed)
- Both TPOAb and TgAb in all the subjects were measured before ART procedure
- Thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L
- Women underwent first embryo transfer without previous IVF history.
Key exclusion criteria (2 listed)
- Abnormal thyroid function test
- Women with known autoimmune diseases or clinical presentations of autoimmune disorders
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 |
|---|---|---|
| Prednisone 10 MG+aspirin 100MGDiscontinue medication based on early pregnancy outcome | Drug | P+A group |
Primary outcome
clinical pregnancy rate
Time frame: 3 mouths
Clinical pregnancy was defined as the existence of a viable embryo within an intrauterine gestational sac
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Undecided. uncertainty
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
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 2 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Jin (13588803459, jin_min@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 3 mouths). 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 29 Jun 2021.