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

Poor Ovarian Response Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02801591
• Other study ID #: GenSci GH AQ CT-POR
• Status: Recruiting
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 12, 2016
• Start date: February 2016

Study information

• Verified date: June 2016
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Rui Yang
• Phone: 010-82265080
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 42 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Poor Ovarian Response

Intervention

Procedure:
• Conventional ovarian stimulation proctol without rhGH

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	People's Hospital of Peking University	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Peking University People's Hospital, 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
Secondary	Number of retrieved oocytes		One year	No
Secondary	Number of high quality embryos		One year	No
Secondary	Number of embryos transferred		One year	No