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Not yet recruitingNCT05578456Updated Oct 13, 2022

Effect of Prednisone and Aspirin on IVF-ET Outcome Among Patients With Thyroid Autoimmunity

A Phase 4 interventional study of Prednisone and Aspirin and Placebo in Thyroiditis, Autoimmune and Infertility, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
540
Allocation
Randomized
Ages
20 Years to 38 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Thyroiditis, Autoimmune
  • Infertility
03

In context

Thyroiditis, Autoimmune

27 studies on the registry are indexed under Thyroiditis, Autoimmune; 4 are open to participants now.

This study's planned enrollment of 540 is above the median of 70 across 19 interventional studies indexed under Thyroiditis, Autoimmune.

Browse Thyroiditis, Autoimmune studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. TPOAb>34IU/ml and/or TgAb>115IU/ml
  2. ≥5 follicles with average diameter lager than 14 mm at trigger day
  3. ≥5 oocytes retrieved
  4. 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
  5. age: 20-38 years old
  6. 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.

Exclusion criteria

Exclusion Criteria:

  • hyperthyroidism
  • intrauterine adhesion
  • with endometrium thickness less than 6mm
  • uterine malformation
  • PGT
  • with other diseases need or aspirin treatment
  • gluacoma
  • gastric ulcer
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
540 participants (estimated)

Study arms

  • Experimental
    prednisone and aspirin

    Drug: Prednisone and Aspirin

  • Placebo comparator
    placebo

    Drug: Placebo

Interventions

  • DrugPrednisone and Aspirin

    Drug pages: Prednisone · Aspirin

    prednisone 10 mg and aspirin 75-100mg per day per os

  • DrugPlacebo

    placebo 2 starch tablets per day per os

06

What researchers measure

Primary outcomes

  1. clinical pregnancy rate

    ultrasound visualization of the gestational sac

    Time frame: 3-5 weeks after embryo transfer

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2022; primary completion for Dec 2025, 37 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2022
First posted
Oct 13, 2022
StartEst.
Nov 1, 2022
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2026
Last update
Oct 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05578456
Collaborators
Ningbo Women & Children's Hospital, Jinhua People's Hospital, Jiaxing Maternity and Child Health Care Hospital
Responsible party
Sponsor
First posted
Oct 13, 2022
Start date
Nov 1, 2022 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 13, 2022

Study contacts

Min Jin, Doctor
Contact
min_jin@zju.edu.cn
+86-15925602121
Min Jin, Doctor
principal investigator · Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Prednisone · Aspirin

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