Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

Qilu Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: Gonal-f ®; Drug: QL1012

Study type: Interventional

Funder types: Industry

Identifiers

NCT05149924

QL1012-002

Details and patient eligibility

About

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.

Enrollment: 354 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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.;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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354 participants in 2 patient groups

QL1012，Recombinant Human Follicle Stimulating Hormone for Injection

Experimental group

Treatment:

Drug: QL1012

Gonal-f ®

Active Comparator group

Treatment:

Drug: Gonal-f ®