Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
NCT ID: NCT05149924
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
354 participants
INTERVENTIONAL
2018-10-31
2019-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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QL1012，Recombinant Human Follicle Stimulating Hormone for Injection
QL1012
Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU
Gonal-f ®
Gonal-f ®
Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU
Interventions
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QL1012
Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU
Gonal-f ®
Subcutaneous injection,starting dose within 75IU \~ 300IU determined by the age , maximum daily dose 450IU
Eligibility Criteria
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Inclusion Criteria
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
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.;
20 Years
39 Years
FEMALE
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The first Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Countries
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Other Identifiers
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QL1012-002
Identifier Type: -
Identifier Source: org_study_id
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