Back to resultsEfficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
QL1012
Gonal-f ®
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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.;
Sites / Locations
- The first Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
QL1012，Recombinant Human Follicle Stimulating Hormone for Injection
Gonal-f ®
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total dose of r-hFSH administered
Number of days of r-hFSH stimulation
Serum estradiol concentration
Endometrial thickness
Fertilization Rate of Oocytes
Rate of high-quality embryos
Implantation rate
clinical pregnancy rate
Ongoing pregnancy rate
Full Information
NCT ID
NCT05149924
First Posted
November 12, 2021
Last Updated
November 25, 2021
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05149924
Brief Title
Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QL1012，Recombinant Human Follicle Stimulating Hormone for Injection
Arm Type
Experimental
Arm Title
Gonal-f ®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
QL1012
Intervention Description
Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU
Intervention Type
Drug
Intervention Name(s)
Gonal-f ®
Intervention Description
Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU
Primary Outcome Measure Information:
Title
Number of oocytes retrieved
Description
36-38 hours after hCG administration, transvaginal ultrasound-guided aspiration was performed as required, and the number of oocytes was recorded.
Time Frame
36-38 hours after hCG administration
Secondary Outcome Measure Information:
Title
Total dose of r-hFSH administered
Time Frame
From date of randomization up to 16 days
Title
Number of days of r-hFSH stimulation
Time Frame
From date of randomization up to 16 days
Title
Serum estradiol concentration
Time Frame
From date of randomization up to 16 days
Title
Endometrial thickness
Time Frame
From date of randomization up to 16 days
Title
Fertilization Rate of Oocytes
Time Frame
Day 1 of IVF/ICSI
Title
Rate of high-quality embryos
Time Frame
3 days after oocyte retrieval
Title
Implantation rate
Time Frame
five to six weeks after oocyte retrieval
Title
clinical pregnancy rate
Time Frame
35 ± 4 days after embryo transfer
Title
Ongoing pregnancy rate
Time Frame
Ten weeks after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.;
Facility Information:
Facility Name
The first Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
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