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

GeneScience Pharmaceuticals (GenSci)

Status: Unknown

Conditions: Poor Ovarian Response

Treatments: Procedure: Conventional ovarian stimulation proctol without rhGH

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02801591

GenSci GH AQ CT-POR

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Female

Ages: 30 to 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 1 patient group

GH AQ

Treatment:

Procedure: Conventional ovarian stimulation proctol without rhGH