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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1012,Recombinant Human Follicle Stimulating Hormone for Injection | Experimental |
| |
| Gonal-f ® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1012 | Drug | Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
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| Gonal-f ® | Drug | Subcutaneous injection,starting dose within 75IU ~ 300IU determined by the age , maximum daily dose 450IU |
|
| 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 |