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The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fang Le Shu | Experimental | Fang Le Shu |
|
| Guo Na Fen | Active Comparator | Guo Na Fen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fang Le Shu (Follitrope) | Drug | rFSH 150 IU, 225 IU, 300 IU per syringe |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | 36 ± 3 hours after HGC trigger |
| Measure | Description | Time Frame |
|---|---|---|
| High quality embryo rate | 3 days after oocyte retrieval | |
| Biochemical pregnancy rate | 14 days after embryo transfer | |
| Clinical pregnancy rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Lead | Contact | +82-2-6987-4147 | lgclinical@lgchem.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
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| Guo Na Fen (Gonal-F) |
| Drug |
rFSH 450 IU per pen |
|
| 5 weeks after embryo transfer |
| Ongoing pregnancy rate | 10 weeks after embryo transfer |
| Miscarriage rate | 28 weeks of gestation |
| Live birth rate | 40 weeks of gestation |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
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