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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
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The aim of this study was to evaluate the efficacy and safety of domestic recombinant human follicle stimulating hormone (rhFSH) stimulating ovarian to promote follicular development before assisted reproductive technology, which was non-inferiority than that of the imported rhFSH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Follitropin | Experimental | Experimental group (domestic rhFSH, powder for injection, 5.5μg (75IU)/vial, initial dose 150-225IU/d, subcutaneous injection, adjust the dose according to ovarian reactivity after 5-7 days of injections, once a day until the HCG trigger day. |
|
| Gonal-F | Active Comparator | Positive control group (imported rhFSH, powder for injection, 5.5μg (75IU)/vial, initial dose 150-225IU/d, subcutaneous injection, adjust the dose according to ovarian reactivity after 5-7 days of injections, once a day until the HCG trigger day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin for Injection | Drug | Drugs for IVF-ET (in vitro fertilization and embryo transfer). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total number of oocytes obtained during the start-up period | Routine ova harvest to determine the number of obtained oocytes | On the days of ovum picking up (hCG trigger 36-38h) |
| Measure | Description | Time Frame |
|---|---|---|
| The number of follicle-1 | The number of follicle with diameter more than 18mm | on the day of hCG day |
| The number of follicle-2 | The number of follicle with diameter more than 18mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Yang | Contact | 010-82265080 | yrjeff@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong Li, Doctor | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| Sun Yat-sen Memorial Hospital |
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| Xiangya Hospital of Central South University |
| OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
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| Recombinant Human Choriogonadotropin alfa Solution for Injection | Drug | Drugs for IVF-ET (in vitro fertilization and embryo transfer). |
|
| Progesterone Soft Capsules | Drug | Drugs for IVF-ET (in vitro fertilization and embryo transfer). |
|
| on the fifth day of rhFSH ovarian stimulation |
| Number of 2PN oocytes | Collected on the day of embryo transfer day after three days of ovum picking up. |
| Number of metaphase II oocytes | Collected on the day of embryo transfer day after three days of ovum picking up, which only collected during ICSI cycle. |
| Number of transferred embryos | Collected on the day of embryo transfer day after three days of ovum picking up. |
| Number of high quality embryos | Collected on the day of embryo transfer day after three days of ovum picking up. |
| Fresh cycle embryo implantation | Collected on the day of embryo transfer day after three days of ovum picking up. |
| rhFSH administered days and vials; administered total dose of rhFSH (IU) | Collected on the day of hCG day. |
| Serum E2 level | Collected on the day of hCG day. |
| High quality embryos rate | Collected on the day of embryo transfer day after three days of ovum picking up. |
| Fertilization rate | Collected on the day of embryo transfer day after three days of ovum picking up. |
| Fresh cycle embryo implantation rate | Collected between 28-35 days after embryo transfer. |
| Biochemical pregnancy rate | Collected between 14-16 days after embryo transfer. |
| Clinical pregnancy rate | Collected between 28-35 days after embryo transfer. |
| Continuous pregnancy rate | Collected after 12 weeks of embryo transfer. |
| The number of follicle-3 | The number of follicle with diameter between 14mm and 18mm. | on the day of hCG day |
| The number of follicle-4 | The number of follicle with diameter less than 14mm | on the day of hCG day |
| Endometrium thickness (mm) | on the day of hCG |
| Guangzhou |
| Guangdong |
| China |
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
| Xiangya Hospital Central South University | Changsha | Hunan | China |
| Women's Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang | China |
| Peking University Third Hospital | Beijing | China |
| Jiangsu Province Hospital | Nanjing | China |
| ID | Term |
|---|---|
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| D007267 | Injections |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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