Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
- Registration Number
- NCT05149924
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 354
Inclusion Criteria
- Signed informed consent
- Aged 20 ~ 39 years(inclusive)
- Body mass index (BMI) between 18~30 kg/m2(inclusive)
- Regular menstrual cycle (25~35 days)
- Basal FSH < 10 IU/L (menstrual cycle day 2~5)
Exclusion Criteria
- History of ≥3 previously completed IVF/ICSI-ET cycles without clinical pregnancy
- History of ≥3 recurrent spontaneous miscarriages
- Patients with high risk of ovarian hyperstimulation syndrome (OHSS)
- Primary ovarian failure or poor responders to ovarian stimulation
- Presence of pregnancy in previous 3 months
- Presence of clinically significant systemic disease, endocrine disease or metabolic abnormalities
- History of malignant tumors of the ovary, breast, uterus, hypothalamus, pituitary gland, etc.;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gonal-f ® Gonal-f ® - QL1012，Recombinant Human Follicle Stimulating Hormone for Injection QL1012 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Fertilization Rate of Oocytes Day 1 of IVF/ICSI clinical pregnancy rate 35 ± 4 days after embryo transfer Endometrial thickness From date of randomization up to 16 days Ongoing pregnancy rate Ten weeks after embryo transfer Total dose of r-hFSH administered From date of randomization up to 16 days Implantation rate five to six weeks after oocyte retrieval Serum estradiol concentration From date of randomization up to 16 days Number of days of r-hFSH stimulation From date of randomization up to 16 days Rate of high-quality embryos 3 days after oocyte retrieval
Trial Locations
- Locations (1)
The first Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The first Affiliated Hospital of Zhengzhou University🇨🇳Zhengzhou, Henan, China