Poor Ovarian ResponseNCT02801591
Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of POR in Patients Undergoing IVF/ET
An observational study of Poor Ovarian Response, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 42 years, women only
- Conditions the study is for
- Poor Ovarian Response
- What is being tested?
- Conventional ovarian stimulation proctol without rhGH
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2016to Feb 2017
- Phase
- Observational
- 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 30 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Poor ovarian response
Who may be able to join
- 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".
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Rui Yang contact
China2 sites, 2 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Rui Yang, 010-82265080
- Not yet recruiting
People's Hospital of Peking University
Beijing
About this study
Official title: 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.
- Conditions
- Poor Ovarian Response
- Being tested
- Conventional ovarian stimulation proctol without rhGH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional ovarian stimulation proctol without rhGHProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| GH AQ | Not described Receives: Procedure: Conventional ovarian stimulation proctol without rhGH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Measured: One year
Secondary outcomes (3)
Number of retrieved oocytes
Measured: One year
Number of high quality embryos
Measured: One year
Number of embryos transferred
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 Poor Ovarian ResponseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Na Chen, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801591
- Sponsor's protocol ID
- GenSci GH AQ CT-POR
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02801591
- Acronym / sponsor ID
- GenSci GH AQ CT-POR
- Conditions
- Poor Ovarian Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Third Hospital, Peking University People's 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GH AQ | – | Procedure: Conventional ovarian stimulation proctol without rhGH |
Who may qualify
- Ages
- 30 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Poor ovarian response
Key inclusion criteria (4 listed)
- 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".
Key exclusion criteria (7 listed)
- 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.
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 ovarian stimulation proctol without rhGH | Procedure or surgery | GH AQ |
Primary outcome
Clinical pregnancy rate
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 embryos transferred
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 16 Jun 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.
Rui Yang contact
Xin Na Chen principal investigator
Peking University Third Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Ovarian Response, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 2 sites 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 4 inclusion and 7 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 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rui Yang (010-82265080), 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). 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 16 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.