Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of POR in Patients Undergoing IVF/ET

• Conditions: Poor Ovarian Response
• Interventions: Procedure: Conventional ovarian stimulation proctol without rhGH

• Registration Number: NCT02801591
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief Summary

Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection assisted in the treatment of the patients with poor ovarian response in vitro fertilization and embryo transfer.

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
• Last Update Submitted: 2016-06-12
• Study First Posted: 2016-06-16
• Last Update Posted: 2016-06-16
• Primary Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Female, age 30-42 years old.
• Diagnosis of POR (2011 ESHRE Bologna Standard).
• At least two previous IVF failure history.
• Voluntarily to sign the "informed consent".

Exclusion Criteria

• Severe acute and chronic liver and kidney disease，Such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity period, etc.；Liver and kidney dysfunction.
• Endocrine and metabolic diseases，eg, diabetes、Thyroid function hyperthyroidism, Thyroid dysfunction, cushing's syndrome, hyperprolactinemia，hyperandrogenism.
• Related diseases affecting outcome of IVF pregnancy，eg, hydrosalpinx, hysteromyoma≥4cm, adenomyosis, stage III and IV endometriosis, untreated endometrial lesions, uterine malformation, genital tuberculosis, malignant tumor of reproductive system （include endometrial carcinoma, cervical carcinoma, ovarian cancer, fallopian tube carcinoma）.
• Allergic to E. coli expression product and its excipients.
• Subjects who participated in the past three months or are participating in other drug clinical researchers.
• IVF failure history≥3.
• The researchers consider who is not suitable for enrolling the group.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GH AQ	Conventional ovarian stimulation proctol without rhGH	-

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	One year

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Peking University Third Hospital; 🇨🇳 Beijing, China

People's Hospital of Peking University; 🇨🇳 Beijing, China