Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS
NCT ID: NCT02801565
Last Updated: 2016-11-28
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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UNKNOWN
NA
208 participants
INTERVENTIONAL
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GH AQ
Controlled ovarian stimulation in the middle of the corpus (D21 days) of the previous menstrual cycle to use recombinant Human Growth Hormone Injection（rhGH） Injection 15IU/5mg/3mL/cartridge, 5IU per day, Subcutaneous injection after 20:00 until the HCG trigger day.
Conventional controlled ovarian stimulation proctol
Conventional controlled ovarian stimulation proctol without rhGH.
Interventions
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Conventional controlled ovarian stimulation proctol
Conventional controlled ovarian stimulation proctol without rhGH.
Eligibility Criteria
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Inclusion Criteria
* BMI≥25kg/m2.
* Diagnosed as PCOS.
* No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease.
* Subjects do not take part in other clinical trial study within 3 months.
* The subjects sign the informed consent form.
Exclusion Criteria
* Hyperprolactinemia and congenital adrenal cortical hyperplasia.
* Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome.
* Pelvic and peritoneal tumor and tumor secreting hyperandrogenism.
* Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity.
* Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level.
* Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma\>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system.
* Allergic to E. coli. expression product and its excipients.
* Being involved in other drug clinical researchers.
* The researchers consider who is not suitable for the group.
25 Years
35 Years
FEMALE
No
Sponsors
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Peking University Third Hospital
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ying Wang
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Ying Wang
Role: primary
Other Identifiers
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GenSci GH AQ CT-PCOS
Identifier Type: -
Identifier Source: org_study_id