Status:
UNKNOWN
Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of POR in Patients Undergoing IVF/ET
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Peking University Third Hospital
Peking University People's Hospital
Conditions:
Poor Ovarian Response
Eligibility:
FEMALE
30-42 years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02801591
Start Date
February 1 2016
Last Update
June 16 2016
Active Locations (2)
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1
Peking University Third Hospital
Beijing, China
2
People's Hospital of Peking University
Beijing, China