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Does oral prednisone improve live birth rates in patients with unexplained recurrent pregnancy loss?A Multicenter, Randomized, Placebo-controlled clinical study

Does oral prednisone improve live birth rates in patients with unexplained recurrent pregnancy loss?A Multicenter, Randomized, Placebo-controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123530
Enrollment
Unknown
Registered
2026-04-27
Start date
2023-10-02
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Experimental group (prednisone group):Oral prednisone
Control group (placebo group):Oral placebo

Sponsors

Hospital Reproductive Medicine Affiliated to ShanDong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 38 Years

Inclusion criteria

Inclusion criteria: 1?Couples with uRPL meet the following conditions: >=2 spontaneous abortions before 28 weeks of pregnancy, and exclude known causes that can lead to recurrent miscarriages (parental chromosomal abnormalities, uterine anatomical abnormalities, endocrine diseases, thrombophilia, and clearly diagnosed autoimmune diseases, etc.); Spontaneous abortion includes: all consecutive or non-consecutive pregnancy losses confirmed by ultrasound or evacuation and histology prior to 28 weeks' gestation, and unobservable pregnancies confirmed by urine or serum hCG positivity (including biochemical pregnancy losses and/or pregnancies of unknown location after absorption and treatment); Ectopic pregnancies and molar pregnancies are not included; 2?IVF/ICSI/PGT-A assisted conception was performed, and frozen embryo transfer was planned; 3?Females are younger than 38 years old at the time of egg retrieval; 4?Number of frozen embryos that can be transferred: >=1 blastocyst or >=2 D3 embryos; 5?Signed informed consent;

Exclusion criteria

Exclusion criteria: 1?Those who are currently taking other glucocorticoid drugs or immunosuppressants, such as hydroxychloroquine, cyclosporine, azathioprine, etc.; 2?Clearly diagnosed immune diseases, such as systemic lupus erythematosus, antiphospholipid syndrome, Sjögren's syndrome, scleroderma, etc; 3?Chromosomal abnormalities of either spouse (except polymorphism); 4?Have the following uterine abnormalities, such as uterine malformations (unicornuate uterus, double uterus); Untreated mediastinal uterus, submucosal fibroids, multiple endometrial polyps, or severe intrauterine adhesions; 5?The endometrial thickness of HCG day < 6mm; 6?Other thrombophilia, endocrine diseases, infectious diseases, etc., which can lead to recurrent miscarriage; 7?Those with contraindications to glucocorticoids; 8?There are contraindications to assisted reproductive technology and pregnancy or diseases that have a definite impact on pregnancy;

Design outcomes

Primary

MeasureTime frame
Live birth rate;

Secondary

MeasureTime frame
The rate of biochemical pregnancy loss.;Good productivity rate;Clinical pregnancy rate;Complete blood count;The clinical pregnancy loss rate.;Adverse reactions and adverse events;Multiple gestation rate;Ongoing pregnancy rate;Complications in newborns and birth defects;Biochemical pregnancy rate;Pregnancy complications;Newborn weight;Alanine aminotransferase and aspartate aminotransferase;Duration of pregnancy;

Countries

China

Contacts

Public ContactNi Tianxiang

Hospital Reproductive Medicine Affiliated to ShanDong University

tianxiangni907@163.com+86 18264151202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026