Status:
UNKNOWN
Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Peking University Third Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
25-35 years
Phase:
NA
Brief Summary
Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.
Eligibility Criteria
Inclusion
- Age between 25 and 35 years old, married female and infertile.
- 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
- BMI\<25kg/m2.
- 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.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT02801565
Start Date
February 1 2016
Last Update
November 28 2016
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China