Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Single-blind, Active-controlled, Phase III Clinical Study to Compare the Efficacy and Safety of QL1012(Recombinant Human Follicle-stimulating Hormone) and Gonal-f ® in Women Undergoing Controlled Ovarian Hyperstimulation for Assisted Reproductive Treatment

Conditions
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Infertility

Intervention / Treatment
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* Drug: QL1012
* Drug: Gonal-f ®


Participation Criteria
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Eligibility Criteria
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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.;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QL1012，Recombinant Human Follicle Stimulating Hormone for Injection<br> | Drug: QL1012<br>* Subcutaneous injection,starting dose within 75IU   300IU determined by the age , maximum daily dose 450IU<br>|
| Active Comparator: Gonal-f ®<br> | Drug: Gonal-f ®<br>* Subcutaneous injection,starting dose within 75IU   300IU determined by the age , maximum daily dose 450IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved | 36-38 hours after hCG administration, transvaginal ultrasound-guided aspiration was performed as required, and the number of oocytes was recorded. | 36-38 hours after hCG administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of r-hFSH administered |  | From date of randomization up to 16 days | 
| 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 | 
| Rate of high-quality embryos |  | 3 days after oocyte retrieval | 
| 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 |