Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

• Status: Completed
• Trial end date: 2019-10-17
• Target enrollment: 0
• Participant gender: Female

Summary

The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Aged 20 ~ 39 years(inclusive)

3. Body mass index (BMI) between 18~30 kg/m2(inclusive)

4. Regular menstrual cycle (25~35 days)

5. Basal FSH < 10 IU/L (menstrual cycle day 2~5)

Exclusion Criteria:

1. History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy

2. History of ≥3 recurrent spontaneous miscarriages

3. Patients with high risk of ovarian hyperstimulation syndrome (OHSS)

4. Primary ovarian failure or poor responders to ovarian stimulation

5. Presence of pregnancy in previous 3 months

6. Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities

7. History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;