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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Poor Ovarian Response
• Intervention / Treatment: Procedure: Conventional ovarian stimulation proctol without rhGH

• Study Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Rui Yang; Phone Number: 010-82265080
  • Beijing, China
    • Not yet recruiting
    • People's Hospital of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Poor ovarian response

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GH AQ	Procedure: Conventional ovarian stimulation proctol without rhGH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical pregnancy rate	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Peking University People's Hospital; Peking University Third Hospital
• Investigators: Principal Investigator: Xin Na Chen, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 12, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 12, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: GenSci GH AQ CT-POR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No