Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS
1 other identifier
interventional
208
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedNovember 28, 2016
June 1, 2016
1 year
June 6, 2016
November 24, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical pregnancy rate
One year
Number of fertilized oocytes
One year
Secondary Outcomes (3)
Number of retrieved oocytes
One year
Number of high quality embryos
One year
Number of transferred embryos
One year
Study Arms (1)
GH AQ
EXPERIMENTALControlled 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.
Interventions
Conventional controlled ovarian stimulation proctol without rhGH.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Wang
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 16, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2017
Last Updated
November 28, 2016
Record last verified: 2016-06