The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;NCT01784380
The Potential Biochemical Diagnosis Criteria and Therapeutic Effect Indexes: Sex Hormone Binding Globulin Levels and Free Androgen Index in Blood of Patients With Polycystic Ovary Syndrome
An observational study of The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group; and At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;, run by Zhongshan Bo Ai Hospital at 2 sites in China.
Trial summary
To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）. Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic effect indicatrixes of women with PCOS. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;, At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;, 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs;
- What is being tested?
- Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin
- How many people
- 1,159 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2006to Oct 2012
- 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 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: The investigators collected 534 PCOS patients as the case group, 580 infertile women with normally ovulatory cycle as the control groupand.The patients of the case group aged from 20 to 42 years old, the average age was 27.87 years old, and the standard deviation of ages was 3.75 years old. And patients' ovulation in the case group was normal, as control group, aged from 20 to 43 years old, the average age was 28.18 years old; the standard deviation of ages was 3.99 years old.Also the investigators also collected 579 patients as the treatment group,who aged from 20 to 39 years, the average age was 27.93 years old, the standard deviation of ages was 3.70 years old.
Who may be able to join
- The clinical diagnosis criteria for PCOS by European Society of Human Reproduction and Embryology, and Rotterdam working group of American Society for Reproductive Medicine (ESHRE /ASRM )
Who cannot join
- hyperprolactinemia and other endocrine diseases such as high androgen hormone in blood, namely Cushing's syndrome, congenital adrenal hyperplasia ( CAH ), ovarian or adrenal tumor and so on
Trial locations and contacts
2 sites in 1 country.
China2 sites
Elecsys2010,French KONTRON EUB-5500 color Doppler ultrasonic diagnostic apparatus
Zhongshan, Guangdong, 528400
Reproductive Center of Bo Ai Hospital, Zhongshan
Zhongshan, Guangdong, 528403
About this study
To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）. Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic effect indicatrixes of women with PCOS.
- Conditions
- The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;, At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;, 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs;, The Investigators Monitored Basic Indexes in Blood of All the Subjects in This Suvey,and Also Monitored Indexes of 579 Patients After Treatment.
- Being tested
- Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropinDrug
| Study group | Role | What they receive |
|---|---|---|
| the case group | Not described | |
| the control group | Not described | |
| the treatment group | Patients of the treatment group recieved drugs,then we observed drugs' treatment effect. Receives: Drug: Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The potentially biochemical diagnosis criteria and therapeutic effect evaluation indexes: Sex hormone binding globulin levels and free androgen index in blood of patients with polycystic ovary syndrome
Measured: after 5 weeks of ovulation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startOct 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;Studies of the same condition, open and under way.
- 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
- Case-control
- Enrolment
- 1,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Bo Ai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN Xiu-feng, Zhongshan Bo Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784380
- Sponsor's protocol ID
- 2006A165
- Status last verified
- Feb 2013
- First submitted
- 30 Jan 2013
- Last updated
- 5 Feb 2013
- Results posted
- No
Publications
Zolghadri J, Tavana Z, Kazerooni T, Soveid M, Taghieh M. Relationship between abnormal glucose tolerance test and history of previous recurrent miscarriages, and beneficial effect of metformin in these patients: a prospective clinical study. Fertil Steril. 2008 Sep;90(3):727-30. doi: 10.1016/j.fertnstert.2007.06.079. Epub 2007 Nov 14.
PubMed 18001723
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Biochemical Diagnosis Criteria and Therapeutic Effect Indexes: Sex Hormone Binding Globulin Levels and Free Androgen Index in Blood of Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01784380
- Acronym / sponsor ID
- 2006A165
- Conditions
- The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group;, At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;, 534 Patients in the Cases Group and 580 Women in the Control Group Received no Measures, While 579 Patients Received Drugs;, The Investigators Monitored Basic Indexes in Blood of All the Subjects in This Suvey,and Also Monitored Indexes of 579 Patients After Treatment.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,159 participants (actual)
- Lead sponsor
- Zhongshan Bo Ai HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Feb 2013 (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.
To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）. Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic effect indicatrixes of women with PCOS.
Study design
- Observational model
- Case-control
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the case group | – | – |
| the control group | – | – |
| the treatment group | – | Drug: Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropinPatients of the treatment group recieved drugs,then we observed drugs' treatment effect. |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The investigators collected 534 PCOS patients as the case group, 580 infertile women with normally ovulatory cycle as the control groupand.The patients of the case group aged from 20 to 42 years old, the average age was 27.87 years old, and the standard deviation of ages was 3.75 years old. And patients' ovulation in the case group was normal, as control group, aged from 20 to 43 years old, the average age was 28.18 years old; the standard deviation of ages was 3.99 years old.Also the investigators also collected 579 patients as the treatment group,who aged from 20 to 39 years, the average age was 27.93 years old, the standard deviation of ages was 3.70 years old.
Key inclusion criteria (1 listed)
- The clinical diagnosis criteria for PCOS by European Society of Human Reproduction and Embryology, and Rotterdam working group of American Society for Reproductive Medicine (ESHRE /ASRM )
Key exclusion criteria (1 listed)
- hyperprolactinemia and other endocrine diseases such as high androgen hormone in blood, namely Cushing's syndrome, congenital adrenal hyperplasia ( CAH ), ovarian or adrenal tumor and so on
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 |
|---|---|---|
| Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin | Drug | the treatment group |
Primary outcome
The potentially biochemical diagnosis criteria and therapeutic effect evaluation indexes: Sex hormone binding globulin levels and free androgen index in blood of patients with polycystic ovary syndrome
Time frame: after 5 weeks of ovulation treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Results publication: PubMed 18001723Zolghadri J, Tavana Z, Kazerooni T, Soveid M, Taghieh M. Relationship between abnormal glucose tolerance test and history of previous recurrent miscarriages, and beneficial effect of metformin in these patients: a prospective clinical study. Fertil Steril. 2008 Sep;90(3):727-30. doi: 10.1016/j.fertnstert.2007.06.079. Epub 2007 Nov 14.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 The Investigators Collected 534 PCOS Patients as the Case Group,and 580 Infertile Women With Normal Ovulatory Cycle of the Control Group; and At the Same Time, the Investigators Continuedly Collect Cases to October 2012, and Totally Collected 579 Patients With PCOS Altogether;, run by Zhongshan Bo Ai Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The potentially biochemical diagnosis criteria and therapeutic effect evaluation indexes: Sex hormone binding globulin levels and free androgen index in blood of patients with polycystic ovary syndrome (time frame: after 5 weeks of ovulation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01784380, which also lists 1 linked publication.
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 5 Feb 2013.