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 range
20 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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);
. Subjects with decreased ovarian reserve;
. TSH test result above or equal to 2.5 mIU/L for subjects with prior hypothyroidism or subclinical hypothyroidism on screening visit;
. Any pregnancy that occurred within 3 months prior to screening visit;