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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02801591
Other study ID # GenSci GH AQ CT-POR
Secondary ID
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. completion date
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


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
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