Overview

Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GeneScience Pharmaceuticals Co., Ltd.
Collaborator:
Peking University Third Hospital
Treatments:
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.