Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of Poor Ovarian Response (POR) Clinical Outcome in Patients Undergoing in Vitro Fertilization / Embryo Transfer (IVF/ET)

Changchun GeneScience Pharmaceutical Co., Ltd.2 sites in 1 country240 target enrollmentFebruary 2016

ConditionsPoor Ovarian Response

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Poor Ovarian Response
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Enrollment: 240
Locations: 2
Primary Endpoint: Clinical pregnancy rate
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

February 2017

Last Updated

9 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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≥
•The researchers consider who is not suitable for enrolling the group.