Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Under… (NCT05738382) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures
China240 participantsStarted 2023-08
Plain-language summary
To explore the optimal effective daily dose of BG2109 to suppress premature luteinizing hormone (LH) surge during COH in female subjects undergoing ART procedures.
Who can participate
Age range20 Years – 39 Years
SexFEMALE
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Inclusion Criteria:
* Married infertile women aged 20 to 39 years (both inclusive), who are diagnosed with tubal infertility, unexplained infertility, grade I-II endometriosis, or spouses diagnosed with male factor infertility, who meet the criteria for IVF and/or ICSI) using fresh or frozen semen from the male spouse or sperm donor
* BMI 18-25 kg/m2 (both inclusive), body weight range 45-80kg (both inclusive)
* Subjects must have regular menstrual cycles, specifically defined as ≥25 days, ≤35 days.
* The serum sex hormone levels during the screening period must be performed in the early follicular phase, and the basal serum follicle-stimulating hormone (FSH) \<10 IU/L, LH, estradiol(E2), prolactin(PRL),testosterone(T) levels are within the laboratory normal range, or the investigator considers them as abnormal but not clinically significant
* The subject is clinically assessed and agree to undergo fresh cycle embryo transfer in the first IVF-ET/ ICSI-Embryo Transfer(ET) cycle, with a maximum of two embryos transferred.
* Within 1 year before randomization, the presence of bilateral ovaries is clearly visible on transvaginal ultrasonography with no significant abnormalities, and appendages are normal. Both ovaries must be available for oocyte retrieval
* Subjects must sign the Informed Consent Form (ICF) and be willing and able to abide by the protocol-specified study procedures
Exclusion Criteria:
* Those who have undergone 2 or more COH of IVF/ICSI-ET before screening, b…
What they're measuring
1
Suppression rate of premature LH surge from the treatment of investigational medicinal products(IMP) until the day of human chorionic gonadotropin(hCG) injection
Timeframe: Through the whole period of administration of IMP,about 5-10 days