Thyroiditis, AutoimmunePhase 4NCT05578456
Effect of Prednisone and Aspirin on IVF-ET Outcome Among Patients With Thyroid Autoimmunity
A Phase 4 study testing Prednisone and Aspirin in people with Thyroiditis, Autoimmune and Infertility, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Thyroiditis, Autoimmune, Infertility
- What is being tested?
- Prednisone and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- TPOAb>34IU/ml and/or TgAb>115IU/ml
- ≥5 follicles with average diameter lager than 14 mm at trigger day
- ≥5 oocytes retrieved
- for frozen embryo transfer, at least 2 cleavage stage embryos, among which at least one morphologically good quality embryo, or at least 1 morphologically good quality embryo in blastocyst stage
- age: 20-38 years old
- Patients whose written ICF approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- meet item 1, 5, 6, and one of item 2, 3, 4.
Who cannot join
- hyperthyroidism
- intrauterine adhesion
- with endometrium thickness less than 6mm
- uterine malformation
- PGT
- with other autoimmune diseases need glucocorticoid or aspirin treatment
- gluacoma
- gastric ulcer
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial
This trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity.
- Conditions
- Thyroiditis, Autoimmune, Infertility
- Being tested
- Prednisone and Aspirin, Placebo
- Medical subject headings
- Thyroiditis, Autoimmune, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone and AspirinDrug
prednisone 10 mg and aspirin 75-100mg per day per os
PlaceboDrug
placebo 2 starch tablets per day per os
| Study group | Role | What they receive |
|---|---|---|
| prednisone and aspirin | Experimental | Not described Receives: Drug: Prednisone and Aspirin |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
ultrasound visualization of the gestational sac
Measured: 3-5 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroiditis, AutoimmuneStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Jinhua People's Hospital, Jiaxing Maternity and Child Health Care Hospital
- Responsible party
- Sponsor
- Investigators
- Min Jin, Doctor, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578456
- Sponsor's protocol ID
- 2022-0513
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05578456
- Acronym / sponsor ID
- 2022-0513
- Conditions
- Thyroiditis, Autoimmune, Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo Women & Children's Hospital, Jinhua People's Hospital, Jiaxing Maternity and Child Health Care Hospital
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Oct 2022 (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.
This trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisone and aspirin | Experimental | Drug: Prednisone and Aspirin |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- TPOAb>34IU/ml and/or TgAb>115IU/ml
- ≥5 follicles with average diameter lager than 14 mm at trigger day
- ≥5 oocytes retrieved
- for frozen embryo transfer, at least 2 cleavage stage embryos, among which at least one morphologically good quality embryo, or at least 1 morphologically good quality embryo in blastocyst stage
- age: 20-38 years old
Key exclusion criteria (8 listed)
- hyperthyroidism
- intrauterine adhesion
- with endometrium thickness less than 6mm
- uterine malformation
- PGT
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 and Aspirinprednisone 10 mg and aspirin 75-100mg per day per os | Drug | prednisone and aspirin |
| Placeboplacebo 2 starch tablets per day per os | Drug | placebo |
Primary outcome
clinical pregnancy rate
Time frame: 3-5 weeks after embryo transfer
ultrasound visualization of the gestational sac
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Min Jin, Doctor principal investigator
Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone and Aspirin in people with Thyroiditis, Autoimmune and Infertility, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Jin, Doctor (+86-15925602121, min_jin@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: 3-5 weeks after embryo transfer). 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 13 Oct 2022.