Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
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
1 other identifier
interventional
354
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2018
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2019
CompletedFirst Submitted
Initial submission to the registry
November 12, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedDecember 8, 2021
November 1, 2021
12 months
November 12, 2021
November 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
QL1012，Recombinant Human Follicle Stimulating Hormone for Injection
EXPERIMENTALGonal-f ®
ACTIVE COMPARATORInterventions
Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU
Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The first Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2021
First Posted
December 8, 2021
Study Start
October 31, 2018
Primary Completion
October 17, 2019
Study Completion
October 17, 2019
Last Updated
December 8, 2021
Record last verified: 2021-11