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

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Conventional controlled ovarian stimulation proctol

• Registration Number: NCT02801565
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-12
• Study First Posted: 2016-06-16
• Last Update Submitted: 2016-11-24
• Last Update Posted: 2016-11-28
• Primary Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GH AQ	Conventional controlled ovarian stimulation proctol	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.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	One year
Number of fertilized oocytes	One year

Secondary Outcome Measures

Name	Time	Method
Number of high quality embryos	One year
Number of transferred embryos	One year
Number of retrieved oocytes	One year

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China