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

NCT ID: NCT02801591

Last Updated: 2016-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Brief Summary

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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

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Conditions

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Poor Ovarian Response

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GH AQ

Conventional ovarian stimulation proctol without rhGH

Intervention Type PROCEDURE

Interventions

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Conventional ovarian stimulation proctol without rhGH

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xin Na Chen

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

People's Hospital of Peking University

Beijing, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Rui Yang

Role: CONTACT

010-82265080

Facility Contacts

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Rui Yang

Role: primary

010-82265080

Other Identifiers

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GenSci GH AQ CT-POR

Identifier Type: -

Identifier Source: org_study_id

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