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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Observation of Recombinant Human Growth Hormone Injection Assisted in Vitro Fertilization and Embryo Transfer (IVF-ET) in the Treatment of Polycystic Ovary Syndrome (PCOS)

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: Conventional controlled ovarian stimulation proctol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GH AQ<br>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. | Drug: Conventional controlled ovarian stimulation proctol<br>* Conventional controlled ovarian stimulation proctol without rhGH.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | One year | 
| Number of fertilized oocytes |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes |  | One year | 
| Number of high quality embryos |  | One year | 
| Number of transferred embryos |  | One year |