Effect of Recombinant Human Growth Hormone Injection on t... | NCT02801591

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

NCT02801591

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Jun 16, 2016Estimated

Enrollment

240Estimated

Phase

Not provided

Conditions

Poor Ovarian Response

Interventions

Conventional ovarian stimulation proctol without rhGH

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Feb 2017Estimated

Completion Date

Not provided

First Submitted Date

Jun 6, 2016

First Submission Date that Met QC Criteria

Jun 12, 2016

First Posted Date

Jun 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2016

Last Update Posted Date

Jun 16, 2016Estimated

Name	Class
Peking University Third Hospital	OTHER
Peking University People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Label	Type	Description	Intervention Names
GH AQ			Procedure: Conventional ovarian stimulation proctol without rhGH

Name	Type	Description	Arm Group Labels	Other Names
Conventional ovarian stimulation proctol without rhGH	Procedure		GH AQ

Measure	Description	Time Frame
Clinical pregnancy rate		One year

Measure	Description	Time Frame
Number of retrieved oocytes		One year
Number of high quality embryos		One year
Number of embryos transferred

Eligibility Module

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≥3.
The researchers consider who is not suitable for enrolling the group.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Poor ovarian response

Sampling Method

Probability Sample