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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801565
• Other study ID #: GenSci GH AQ CT-PCOS
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2016
• Last updated: November 24, 2016
• Start date: February 2016

Study information

• Verified date: June 2016
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Shuo Huang
• Phone: 010-82265080
• Email: homelyleaf[@]aliyun.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Conventional controlled ovarian stimulation proctol
Conventional controlled ovarian stimulation proctol without rhGH.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		One year	No
Primary	Number of fertilized oocytes		One year	No
Secondary	Number of retrieved oocytes		One year	No
Secondary	Number of high quality embryos		One year	No
Secondary	Number of transferred embryos		One year	No