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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801565
Recruitment Status : Unknown
Verified June 2016 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : November 28, 2016
Sponsor:
Collaborator:
Peking University Third Hospital
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Conventional controlled ovarian stimulation proctol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2016
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GH AQ
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.
Drug: Conventional controlled ovarian stimulation proctol
Conventional controlled ovarian stimulation proctol without rhGH.




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: One year ]
  2. Number of fertilized oocytes [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Number of retrieved oocytes [ Time Frame: One year ]
  2. Number of high quality embryos [ Time Frame: One year ]
  3. Number of transferred embryos [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801565


Contacts
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Contact: Shuo Huang 010-82265080 homelyleaf@aliyun.cn

Locations
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China
Peking University Third Hospital Recruiting
Beijing, China
Contact: Ying Wang    010-82265080      
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Peking University Third Hospital
Investigators
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Principal Investigator: Ying Wang Peking University Third Hospital
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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02801565    
Other Study ID Numbers: GenSci GH AQ CT-PCOS
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases