Infertility, Thyroiditis, Autoimmune
Conditions
Brief 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.
Interventions
DRUGPrednisone and Aspirin
prednisone 10 mg and aspirin 75-100mg per day per os
DRUGPlacebo
placebo 2 starch tablets per day per os
Sponsors
Ningbo Women & Children's Hospital
Jinhua People's Hospital
Jiaxing Maternity and Child Health Care Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No
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
* hyperthyroidism * intrauterine adhesion * with endometrium thickness less than 6mm * uterine malformation * PGT * with other autoimmune diseases need glucocorticoid or aspirin treatment * gluacoma * gastric ulcer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | 3-5 weeks after embryo transfer | ultrasound visualization of the gestational sac |
Contacts
Primary ContactMin Jin, Doctor
Outcome results
None listed