Polycystic Ovary SyndromeNCT02801565
Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS
A study of Polycystic Ovary Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Ying Wang, 010-82265080
About this study
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)
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Conventional controlled ovarian stimulation proctol
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional controlled ovarian stimulation proctolDrug
Conventional controlled ovarian stimulation proctol without rhGH.
| Study group | Role | What they receive |
|---|---|---|
| GH AQ | Experimental | 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. Receives: Drug: Conventional controlled ovarian stimulation proctol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: One year
Number of fertilized oocytes
Measured: One year
Secondary outcomes (3)
Number of retrieved oocytes
Measured: One year
Number of high quality embryos
Measured: One year
Number of transferred embryos
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Third Hospital
- Responsible party
- Sponsor
- Investigators
- Ying Wang, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801565
- Sponsor's protocol ID
- GenSci GH AQ CT-PCOS
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02801565
- Acronym / sponsor ID
- GenSci GH AQ CT-PCOS
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Third Hospital
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GH AQ | Experimental | Drug: Conventional controlled ovarian stimulation proctolControlled 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional controlled ovarian stimulation proctolConventional controlled ovarian stimulation proctol without rhGH. | Drug | GH AQ |
Primary outcome
Clinical pregnancy rate
Time frame: One year
Number of fertilized oocytes
Time frame: One year
3 secondary outcomes
Number of retrieved oocytes
Time frame: One year
Number of high quality embryos
Time frame: One year
Number of transferred embryos
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Wang principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Polycystic Ovary Syndrome, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuo Huang (010-82265080, homelyleaf@aliyun.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.