To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in I… (NCT05994378) | Clinical Trial Compass
CompletedPhase 3
To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects
China317 participantsStarted 2023-08-29
Plain-language summary
This study is a multi-center, randomized, double-blind, positive drug-controlled, non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.
Who can participate
Age range20 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Married infertile female subjects aged 20 to 39 years with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);
✓. Body mass index (BMI) 18 \~ 28kg/m2 (both exclusive) and weight 45Kg \~ 75Kg (both inclusive);
✓. Regular menstrual cycle (24 \~ 35 days, both inclusive) for the last 3 months prior to screening;
✓. Anticipated normal ovarian response;
✓. Willingness of the subject to undergo fresh cycle transfer with one or two embryos at a time in the first IVF-ET cycle；
✓. Normal cervical cytology results (TCT) or with limited clinically significance within 1 year prior to screening or on the screening visit; or subjects with atypical squamous cells of undetermined significance (ASC-US) of TCT tested negative for high-risk types of human papillomavirus (HPV);
✓. Informed consent of subjects and their spouses;
Exclusion criteria
✕. Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancy；
✕. Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement in related medical condition;
✕. Subjects with more than 2 times of spontaneous abortion;
✕. Subjects at high risk of OHSS, judged by the investigator according to the Golan classification (e.g., those with moderate to severe OHSS during previous COH cycles, polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS);