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

ConditionsThyroiditis, AutoimmuneInfertility
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-38
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

hyperthyroidism

intrauterine adhesion

with endometrium thickness less than 6mm

uterine malformation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisone and Aspirin

    Drug

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

  • Placebo

    Drug

    placebo 2 starch tablets per day per os

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: prednisone and aspirinExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

clinical pregnancy rate

ultrasound visualization of the gestational sac

Time frame
3-5 weeks after embryo transfer

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Ningbo Women & Children's Hospital

Collaborator

Jinhua People's Hospital

Collaborator

Jiaxing Maternity and Child Health Care Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: