Efficacy and Safety of BG2109 During Controlled Ovarian Hyperstimulation in Female Subjects Undergoing ART Procedures

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio Genuine (Shanghai) Biotech Co., Ltd.
• Treatments: Cetrorelix

Criteria

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, but have not achieved clinical pregnancy.

• Those with previous IVF or ART failure due to sperm/fertilization problems whose related medical condition has not been improved.

• Either subjects or their spouses or both of them are known to carry abnormal chromosomal structures, or patients known to have single-gene genetic diseases or serious diseases with genetic susceptibility requiring Preimplantation Genetic Diagnosis(PGD) before embryo transfer.

• Those with high risk of ovarian hyperstimulation syndrome(OHSS)

• Those with low ovarian function at screening, with at least one of the following: poor ovarian response in the past; less than 6 antral follicles (AFC) with a diameter of < 10 mm seen on bilateral ovary transvaginal ultrasonography at Day2-3 of menstrual cycle; anti-mullerian hormone(AMH) < 1.1 ng/ml.

• Subjects who used gonadotropins for ovarian stimulation or drugs that affect ovarian function within 30 days prior to screening.

• Subjects with abnormal thinprep cytology test(TCT) results that are judged by the investigator as clinically significant and require treatment within 6 months before screening.

• As judged by the investigator, subjects with clinically significant gynecological diseases at screening

• Those previously or prior randomization suffering from the cancer of uterine, ovarian, breast or hypothalamus or pituitary gland.

• Those with a positive serum β-hCG test result at the screening visit or the visit on Day 1 of ovarian stimulation.

• During COH, LH ≥10 U/L, and the LH level was 2.5 times higher than the baseline value before D0 (inclusive).