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The effect of flexibly reducing the dose of GnRH antagonist and adding low dose prednisone on clinical pregnancy rate in IVF antagonist cycles: a multicenter randomized controlled trial

The effect of flexibly reducing the dose of GnRH antagonist and adding low dose prednisone on clinical pregnancy rate in IVF antagonist cycles

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021024
Enrollment
Unknown
Registered
2019-01-25
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Infertility

Interventions

Group A:Centrotide, 0.125mg/d
Group B (Prednisone):0.25mg/d Cetrotide,and 10mg qd Prednisone is administered orally
Group C (conventional GnRH antagonist protocol):0.25mg/d Centrotide

Sponsors

Ruijin Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20 to 35 years; 2. GnRH antagonist protocol is employed for IVF/ICSI and will be followed by fresh embryo transfer; 3. Patients must agree and sign the informed consent and comply with the trial requirements.

Exclusion criteria

Exclusion criteria: 1. Reduced ovarian reserve (criteria: FSH > 15IU/L, bilateral AFCs < 5, AMH < 1.1ng/L); 2. PCOS patients with uncontrolled androgen; 3. Untreated hydrosalpinx; 4. Untreated endometrial polyps; 5. Moderate to severe intrauterine adhesions; 6. Endometriosis, adenomyosis, hysteromyoma (except subserous myoma); 7. Have experienced spontaneous abortion or implantation failure for twice or more; 8. Thyroid dysfunction, immune abnormality and insulin resistance not treated to normal level; 9. There are other internal and surgical diseases that are unsuitable for or have impact on pregnancy; 10. Known drug-related contraindications (e.g. allergy to Cetrotide, or known contraindications for glucocorticoid).

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate (number of pregnant cases which are confirmed by ultrasound/ total number of transplanted cases);

Secondary

MeasureTime frame
Biochemical pregnancy rate (number of pregnant cases which are confirmed by blood ß-hCG examination / number of transplanted cases);implantation rate (number of gestational sacs / number of transplanted embryos);early miscarriage rate (number of miscarriage cases / number of pregnant cases confirmed by ultrasound);late miscarriage rate (number of miscarriage cases / number of pregnant cases confirmed by ultrasound);premature birth rate (number of premature births/ number of pregnant cases confirmed by ultrasound);live birth rate (number of deliveries / number of transplantation cycles);mean number of retrieved oocytes;fertilization rate (number of fertilized oocytes / number of retrieved oocytes);available embryo rate (number of D3 available embryos / number of embryos);rate of high quality embryos [number of D3 high quality embryos (=7 score)/ number of embryos];rate of cycle cancelation due to premature ovulation (number of cancelled cycles due to premature ovulation / number of total cycles in the specific group), rate of adverse effect.;

Countries

China

Contacts

Public ContactBufang Xu

Ruijin Hospital of Shanghai

bufangxu@163.com+86 13916992658

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026