Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subje… (NCT07236476) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
China90 participantsStarted 2024-10-09
Plain-language summary
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI). Three LY01021 dose groups of 40 mg QD, 30 mg QD, and 20 mg QD will be included, with not exceed 45 subjects in each group to investigate the efficacy and safety.
Who can participate
Age range20 Years – 39 Years
SexFEMALE
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Inclusion Criteria:
* Informed consent of subjects and their spouses;
* Married infertile female subjects aged 20 to 40 years (40 years exclusive) with indications for in vitro fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);
* Weight 45Kg \~ 80Kg (both inclusive), and body mass index (BMI) 19.0 \~ 28.0kg/m2;
* 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 cycleï¼›
* Normal cervical cytology results (TCT) or with limited clinically significance within 6 months prior to screening; or subjects with atypical squamous cells of undetermined significance (ASC-US) of TCT tested negative for high-risk types of human papillomavirus (HPV).
Exclusion Criteria:
* Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without achieving clinical pregnancyï¼›
* Previous IVF/ ICSI failure due to sperm/fertilization problems/low fertilization rate(\<30%) 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 low ovari…