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Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional controlled ovarian stimulation proctol
Sponsored by
Changchun GeneScience Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 25 and 35 years old, married female and infertile.
  • BMI≥25kg/m2.
  • Diagnosed as PCOS.
  • No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease.
  • Subjects do not take part in other clinical trial study within 3 months.
  • The subjects sign the informed consent form.

Exclusion Criteria:

  • BMI<25kg/m2.
  • Hyperprolactinemia and congenital adrenal cortical hyperplasia.
  • Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome.
  • Pelvic and peritoneal tumor and tumor secreting hyperandrogenism.
  • Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity.
  • Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level.
  • Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system.
  • Allergic to E. coli. expression product and its excipients.
  • Being involved in other drug clinical researchers.
  • The researchers consider who is not suitable for the group.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GH AQ

Arm Description

Controlled ovarian stimulation in the middle of the corpus (D21 days) of the previous menstrual cycle to use recombinant Human Growth Hormone Injection（rhGH） Injection 15IU/5mg/3mL/cartridge, 5IU per day, Subcutaneous injection after 20:00 until the HCG trigger day.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
Number of fertilized oocytes

Secondary Outcome Measures

Number of retrieved oocytes
Number of high quality embryos
Number of transferred embryos

Full Information

First Posted
June 6, 2016
Last Updated
November 24, 2016
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02801565
Brief Title
Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS
Official Title
Clinical Observation of Recombinant Human Growth Hormone Injection Assisted in Vitro Fertilization and Embryo Transfer (IVF-ET) in the Treatment of Polycystic Ovary Syndrome (PCOS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking University Third Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GH AQ
Arm Type
Experimental
Arm Description
Controlled ovarian stimulation in the middle of the corpus (D21 days) of the previous menstrual cycle to use recombinant Human Growth Hormone Injection（rhGH） Injection 15IU/5mg/3mL/cartridge, 5IU per day, Subcutaneous injection after 20:00 until the HCG trigger day.
Intervention Type
Drug
Intervention Name(s)
Conventional controlled ovarian stimulation proctol
Intervention Description
Conventional controlled ovarian stimulation proctol without rhGH.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
One year
Title
Number of fertilized oocytes
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number of retrieved oocytes
Time Frame
One year
Title
Number of high quality embryos
Time Frame
One year
Title
Number of transferred embryos
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 25 and 35 years old, married female and infertile. BMI≥25kg/m2. Diagnosed as PCOS. No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease. Subjects do not take part in other clinical trial study within 3 months. The subjects sign the informed consent form. Exclusion Criteria: BMI<25kg/m2. Hyperprolactinemia and congenital adrenal cortical hyperplasia. Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome. Pelvic and peritoneal tumor and tumor secreting hyperandrogenism. Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity. Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level. Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system. Allergic to E. coli. expression product and its excipients. Being involved in other drug clinical researchers. The researchers consider who is not suitable for the group.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo Huang
Phone
010-82265080
Email
homelyleaf@aliyun.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Wang
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Wang
Phone
010-82265080

12. IPD Sharing Statement

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Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS

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