Overview
Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
GeneScience Pharmaceuticals Co., Ltd.Collaborator:
Peking University Third HospitalTreatments:
Hormones
Criteria
Inclusion Criteria:- 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 Criteria:
- 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.