Infertility
Conditions
Brief 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.
Interventions
DRUGQL1012
Subcutaneous injection,starting dose within 75IU \ 300IU determined by the age , maximum daily dose 450IU
DRUGGonal-f ®
Subcutaneous injection,starting dose within 75IU \ 300IU determined by the age , maximum daily dose 450IU
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
No
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.;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes retrieved | 36-38 hours after hCG administration | 36-38 hours after hCG administration, transvaginal ultrasound-guided aspiration was performed as required, and the number of oocytes was recorded. |
Secondary
| Measure | Time frame |
|---|---|
| Number of days of r-hFSH stimulation | From date of randomization up to 16 days |
| Serum estradiol concentration | From date of randomization up to 16 days |
| Endometrial thickness | From date of randomization up to 16 days |
| Fertilization Rate of Oocytes | Day 1 of IVF/ICSI |
| Total dose of r-hFSH administered | From date of randomization up to 16 days |
| Implantation rate | five to six weeks after oocyte retrieval |
| clinical pregnancy rate | 35 ± 4 days after embryo transfer |
| Ongoing pregnancy rate | Ten weeks after embryo transfer |
| Rate of high-quality embryos | 3 days after oocyte retrieval |
Countries
China
Outcome results
None listed