Polycystic Ovarian SyndromeWHINCT01838122
Prevalence of HbA1C in Women With PCOS
An observational study of Polycystic Ovarian Syndrome and Pelvic Endometriosis, run by Southern Cross Fertility Centre at 1 site in India.
Trial summary
Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome, Pelvic Endometriosis, Insulin Resistance
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2013to Nov 2013
- 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 15 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: This population will have subjects with diagnosis of PCOS,by Rotterdam criteria regardless of complain(s)
Who may be able to join
- BMI of 25-35 Kg/Mt2
- Atleast three of the Rotterdam criteria for diagnosis of PCOS.
- Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder.
Who cannot join
- Subjects with documented diagnosis of Metabolic Syndrome.
- Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia.
- 4.Subjects with basal FSH >/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study
Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.
Read the detailed description
In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS.
Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests.
Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.
- Conditions
- Polycystic Ovarian Syndrome, Pelvic Endometriosis, Insulin Resistance, Non-insulin Dependent Diabetes Mellitus, Tubal Obstruction
- Keywords
- PCOS, HbA1C, Insulin resistance, OGTT, HOMA-IR, HOMA-B-cell
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Diabetes Mellitus, Type 2, Fallopian Tube Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria) | |
| Control arm | This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HbA1C in both arms of the cohort of subjects
HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS
Measured: September 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013 (estimated)
- Study completionNov 2013 (estimated)
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 Polycystic Ovarian SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Cross Fertility Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.R. Bharucha, Southern Cross Fertility Centre
- Investigators
- Manchi R Bharucha, Ph.D, Study director, Southern Cross Fertility CentreManchi R Bharucha, Ph.D., Study director, Souther Cross Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838122
- Sponsor's protocol ID
- HbA1C-PCOS
- Other IDs
- PCOS-IR
- Acronym
- WHI
- Status last verified
- Apr 2013
- First submitted
- 15 Apr 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jin JU Kim,Young Min Choi et al.Human Reproduction 27(5),1439-1444,2013.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HbA1C in Different Categories of Obesity in Women With PCOS'A Propective Randomized Control Study
- ClinicalTrials.gov ID
- NCT01838122
- Acronym / sponsor ID
- WHI / HbA1C-PCOS
- Conditions
- Polycystic Ovarian Syndrome, Pelvic Endometriosis, Insulin Resistance, Non-insulin Dependent Diabetes Mellitus, Tubal Obstruction
- Keywords
- PCOS, HbA1C, Insulin resistance, OGTT, HOMA-IR, HOMA-B-cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Southern Cross Fertility CentreUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 23 Apr 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.
Women with PCOS have been observed to be potential diabetics.Recently,American Diabetes Association has suggested screening of women with PCOS for HbA1C.
Detailed description
In view of recent suggestion of American Diabetes Association(ADA)to screen women with PCOS for HbA1C,we intend to study its prevalence in all categories of obesity in women with PCOS.
Women with PCOS by Rotterdam criteria will be screened for insulin resistance by using different techniques or tests.
Further, the sensitivity and specificity of HbA1C will be compared with sensitivity and specificity of other insulin resistance markers such as OGTT, Free androgen index, free testosterone, fasting insulin to glucose ratio, HOMA-IR and HOMA-B-CELL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | – | –This group/cohort will have subjects having infertility due to PCOS (as per Rotterdam criteria) |
| Control arm | – | –This group/cohort will have subjects without PCOS but with any other diagnosis of infertility or any other complain. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This population will have subjects with diagnosis of PCOS,by Rotterdam criteria regardless of complain(s)
Key inclusion criteria (3 listed)
- BMI of 25-35 Kg/Mt2
- Atleast three of the Rotterdam criteria for diagnosis of PCOS.
- Subjects with well stabilized Thyroid,if they had documented evidence of previousthyroid disorder.
Key exclusion criteria (3 listed)
- Subjects with documented diagnosis of Metabolic Syndrome.
- Subjects with laparocopic and histopathologic diagnosis of Endometriosis. 3Subjects with Primary hyperprolectineamia.
- 4.Subjects with basal FSH >/=15mIU/ml. 5.Subjects with continuously elevated 17-0h-p.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of HbA1C in both arms of the cohort of subjects
Time frame: September 2013
HbA1C has been suggested as a potential marker for NIDDM in subjects with PCOS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Results publicationJin JU Kim,Young Min Choi et al.Human Reproduction 27(5),1439-1444,2013.
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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.
Manchi R Bharucha, Ph.D study director
Southern Cross Fertility Centre
Manchi R Bharucha, Ph.D. study director
Souther Cross Fertility Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome and Pelvic Endometriosis, run by Southern Cross Fertility Centre at 1 site in India.
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 3 inclusion and 3 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 23 Apr 2013. 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 India. 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?
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?
Prevalence of HbA1C in both arms of the cohort of subjects (time frame: September 2013). 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 NCT01838122, 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 23 Apr 2013.