Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926115
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-06-01
Brief Title:
Phenotype and Epidemiology of the Polycystic Ovary Syndrome PCOS in Colombia PEP - Colombia Study
Sponsor:
Instituto de fertilidad humana InSer
Organization:
Instituto de fertilidad humana InSer
Study Overview
Official Title:
Phenotype and Epidemiology of the Polycystic Ovary Syndrome PCOS in Colombia PEP - Colombia Study
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEP-Colombia
Brief Summary:
The goal of this observational study is to know the prevalence of PCOS among economically productive and reproductive age women from Medellín and the Valle de Aburrá Colombia The main questions it aims to answer are
1 What is the phenotypic distribution of PCOS detected in women seeking medical attention as a requirement for employment in Medellín and the Valle de Aburrá Colombia
2 What is the effect of environmental factors such as geographical location and diet and biological factors such as obesity and ethnicityrace on the prevalence and phenotype of PCOS in this populatión
Participants will undergo anthropometric measurements and physical examination for hirsutism acne alopecia acanthosis nigricans and thyroid enlargement During the initial visit a transvaginal or transabdominal pelvic ultrasonography will be performed A sample of venous blood will be collected in plain tubes for serum cryopreservation and for immediate glucose estimation Some participants will be rescheduled for a second evaluation visit for additional assessment when they have a possible PCOs
1 What is the phenotypic distribution of PCOS detected in women seeking medical attention as a requirement for employment in Medellín and the Valle de Aburrá Colombia
2 What is the effect of environmental factors such as geographical location and diet and biological factors such as obesity and ethnicityrace on the prevalence and phenotype of PCOS in this populatión
Participants will undergo anthropometric measurements and physical examination for hirsutism acne alopecia acanthosis nigricans and thyroid enlargement During the initial visit a transvaginal or transabdominal pelvic ultrasonography will be performed A sample of venous blood will be collected in plain tubes for serum cryopreservation and for immediate glucose estimation Some participants will be rescheduled for a second evaluation visit for additional assessment when they have a possible PCOs
Detailed Description:
During the first visit potential study participants scheduled for routine occupational pre-admission medical examination at Colmédicos Medical Centre will be invited to participate in the study Eligible study participants will be counselled on the objectives of the study and the study protocol and a copy of the consent form will be handed to them A confidential study register containing details of potential study participants name age height weight and contact will be start on the first visit day Informed written consent will be obtained from each study participant before recruitment for the study in the evaluation visit number one All study participants personal data will be protected according to the law ley 1581de Colombia
1 Evaluation Visit 1
After obtaining an informed consent data will be collected from each study participant using a standard format in a clinical report form CRF for uniform data collection from all participants Each CRF will bear a unique serial identification number and will be written in the local language The CRF will be filled by a trained researcher including the PI co-investigators and medically trained research assistants All CRF will be checked for missing data within 24 hours of completion and any missing data will be detected and collected immediately At no time will the study personnel have access to the participants medical occupational records following the restrictions defined in the colombian legislation resolution 2346 de 2007 R 1918 de 2011
Each participant will undergo anthropometric measurements weight height waist circumference and hip circumference and physical examination for hirsutism acne alopecia acanthosis nigricans and thyroid enlargement Participants with an initial hirsutism mFG score of 4 or more 4 will be re-assessed by a physician During the initial visit at Colmédicos a transvaginal or transabdominal pelvic ultrasonography will be performed in all participants based on the sexual history and consent form by trained gynecologists who are part of study investigators A transvaginal ultrasound is the accepted and validated method to assess the ovarian morphology in the study of patients with PCOS
After an overnight fast of at least 6 hours ideally a 18 ml sample of venous blood will be collected from each study participant ie the basal fasting sample About 12 ml of the venous blood will be collected in plain tubes for serum cryopreservation and subsequent analysis and the remainder in plain tubes for immediate glucose estimation in serum
2 Sample Processing
The initial blood specimens will be labeled with the participants unique ID number time and date of blood collection and date of last menstrual period LMP The samples will be obtained by trained laboratory personnel from Colmédicos medical center during the morning hours 0800 to 1000 hours regardless of the participants menstrual cycle Participants with oligomenorrhoea or amenorrhoea will have a urine pregnancy done test prior to blood sampling
At Colmédicos laboratory the blood samples will be separated into serum plasma and whole blood by centrifugation for 20 minutes at 3000 rpm The biological specimens will be stored in small aliquots of 125 ml in 15 to 20 ml plastic containers about 4 cryovials able to withstand temperatures of -80 degrees centigrade The aliquoted samples will be sent to the ABAD Zona 2 SUR laboratory Carrera 32 No 2 Sur 47 local 9701 in dry ice containers by the laboratorys courier staff where they will be stored at -20 degrees centigrade for a maximum of 3 months for processing If necessary for longer storage the samples will be transferred to the Inser Medellin laboratory and stored at -80 degrees centigrade where they will remain in custody until their use or final disposal according to the established institutional waste management protocol
3 Hormonal chemical analyses
Samples for hormonal assay and the initial evaluation will be batched at regular intervals for the analysis every week to provide the study participants with timely results allow classification of participants and minimize the impact of inter-assay variability In addition this will allow us to timely contact participants who require additional studies
All participants will be evaluated in a uniform manner regardless of the phase of the cycle in which they are
4 Evaluating subjects with Possible PCOS
The cohort of participants who initially meet clinical features suggestive of PCOS ie HA OA or PCOM will be designated as Possible PCOS and will undergo the following measurements in their samples
1 In all Possible PCOS subjects TSH prolactin PRL and 17-HP will be measured in the basal serum samples as well as fasting glucose
Note All subjects diagnosed with PCOS should have a normal TSH PRL and 17-HP basally or after acute ACTH stimulation
2 In women presenting clinically with HAOA if the TV-US performed demonstrates PCOM the subject is classified as having PCOS phenotype A HAOAPCOM if not the subject is classified as having PCOS phenotype B HAOA
3 Subjects presenting clinically with HA only will return during the luteal phase days 21-24 of their menstrual cycle for a serum progesterone P4 level Subjects with HA who demonstrate OA ie luteal P4 3 ngmL will be classified as having PCOS phenotype A if they have PCOM by TV-US HAOAPCOM or PCOS phenotype B HAOA if they do not exhibit PCOM HA subjects who also demonstrate PCOM but no OA ie luteal P4 3 ngmL will be classified as PCOS phenotype C Participants with HA but no PCOM or OA will be classified as having isolated HA
4 Subjects presenting clinically with OA only their basal serum samples will be assayed for androgen levels total TT and free testosterone FT dehydroepiandrosterone sulphate DHEAS and androstenedione A4 Subjects with OA who demonstrate HA ie elevated androgen levels will be classified as having PCOS phenotype A if they have PCOM by TV-US HAOAPCOM or PCOS phenotype B HAOA if they do not exhibit PCOM OA subjects who also demonstrate PCOM but no HA ie normal androgen levels will be classified as PCOS phenotype D Participants with OA but no PCOM or HA will be classified as having isolated OA
5 Subjects presenting with PCOM by TV-US will return during the luteal phase days 22-24 of their menstrual cycle for a serum progesterone P4 level and their basal serum samples will be assayed for androgen levels total TT and free testosterone FT dehydroepiandrosterone sulphate DHEAS and androstenedione A4 Subjects with PCOM who demonstrate OA ie luteal P4 3 ngmL will be classified as having PCOS phenotype D If they also demonstrate HA ie elevated androgen levels HAOAPCOM will be classified as having PCOS phenotype A PCOM subjects who also demonstrate HA but no OA ie luteal P4 3 ngmL will be classified as PCOS phenotype C Participants with PCOM but no HA or OA will be classified as having isolated PCOM
5 Diagnosing PCOS
Related or mimicking disorders will be excluded using history physical examination and serum TSH PRL and 17-OHP Study participants with a basal 17-OHP 2 ngml or 200 ngdl will undergo a repeat 17-OHP measurement in the follicular phase and if the 17-OHP is still 2ngmL an acute adrenocorticotrophic hormone ACTH stimulation test will be performed to exclude non-classical congenital adrenal hyperplasia NCAH We estimate considering our previous data that approximately 6 of subjects screened will require an acute ACTH stimulation test
Overall PCOS will be diagnosed when subjects present with either HAOAPCOM phenotype A HAOA phenotype B HAPCOM phenotype C and OAPCOM phenotype D and demonstrate normal levels of TSH 037 to 47 mUIL PRL 25 ngmL and 17-OHP per our diagnostic algorithm
6 Evaluation visit 2
In the following cases subjects will be rescheduled for a second evaluation visit evaluation visit 2 for additional assessment
1 All subjects with PCOS will be scheduled for a return visit to undergo a 2-hour 75g oral glucose tolerance test OGTT with 3 ml of venous blood collected in serum tubes at 0 minutes and at 120 minutes post-glucose load Glucose and insulin from serum tubes levels will be assessed at 0 and 120 min
2 Participants will be reevaluated during the follicular phase of the menstrual cycle between day 1 and 5
i With a repeat ultrasound in case there is a dominant follicle 10 mm or an ovarian cyst at the initial ultrasound evaluation
ii A repeat 17-hydroxyprogesterone 17-OHP measurement in the event the initial 17-OHP is 2 ngmL and was obtained during the luteal phase according to menstrual history Approximately 50 of Participants evaluated in luteal phase are expected to have a 17-OHP 2 ngmL
iii An acute intravenous iv ACTH-1-24 025 mg stimulation test if the initial and repeat 17-OHP obtained during the follicular phase according to menstrual history is 2 ngmL
7 Reassessing hormonal levels
At the completion of the study a repeat analysis of the samples for androgen levels in all PCOS subjects and a group of super-controls 30 controls will be performed at a reference laboratory A fasting glucose level also be analyzed in a group of super controls 100 controls Genetic analysis could be performed depending on the availability of financial support in a reference laboratory
1 Evaluation Visit 1
After obtaining an informed consent data will be collected from each study participant using a standard format in a clinical report form CRF for uniform data collection from all participants Each CRF will bear a unique serial identification number and will be written in the local language The CRF will be filled by a trained researcher including the PI co-investigators and medically trained research assistants All CRF will be checked for missing data within 24 hours of completion and any missing data will be detected and collected immediately At no time will the study personnel have access to the participants medical occupational records following the restrictions defined in the colombian legislation resolution 2346 de 2007 R 1918 de 2011
Each participant will undergo anthropometric measurements weight height waist circumference and hip circumference and physical examination for hirsutism acne alopecia acanthosis nigricans and thyroid enlargement Participants with an initial hirsutism mFG score of 4 or more 4 will be re-assessed by a physician During the initial visit at Colmédicos a transvaginal or transabdominal pelvic ultrasonography will be performed in all participants based on the sexual history and consent form by trained gynecologists who are part of study investigators A transvaginal ultrasound is the accepted and validated method to assess the ovarian morphology in the study of patients with PCOS
After an overnight fast of at least 6 hours ideally a 18 ml sample of venous blood will be collected from each study participant ie the basal fasting sample About 12 ml of the venous blood will be collected in plain tubes for serum cryopreservation and subsequent analysis and the remainder in plain tubes for immediate glucose estimation in serum
2 Sample Processing
The initial blood specimens will be labeled with the participants unique ID number time and date of blood collection and date of last menstrual period LMP The samples will be obtained by trained laboratory personnel from Colmédicos medical center during the morning hours 0800 to 1000 hours regardless of the participants menstrual cycle Participants with oligomenorrhoea or amenorrhoea will have a urine pregnancy done test prior to blood sampling
At Colmédicos laboratory the blood samples will be separated into serum plasma and whole blood by centrifugation for 20 minutes at 3000 rpm The biological specimens will be stored in small aliquots of 125 ml in 15 to 20 ml plastic containers about 4 cryovials able to withstand temperatures of -80 degrees centigrade The aliquoted samples will be sent to the ABAD Zona 2 SUR laboratory Carrera 32 No 2 Sur 47 local 9701 in dry ice containers by the laboratorys courier staff where they will be stored at -20 degrees centigrade for a maximum of 3 months for processing If necessary for longer storage the samples will be transferred to the Inser Medellin laboratory and stored at -80 degrees centigrade where they will remain in custody until their use or final disposal according to the established institutional waste management protocol
3 Hormonal chemical analyses
Samples for hormonal assay and the initial evaluation will be batched at regular intervals for the analysis every week to provide the study participants with timely results allow classification of participants and minimize the impact of inter-assay variability In addition this will allow us to timely contact participants who require additional studies
All participants will be evaluated in a uniform manner regardless of the phase of the cycle in which they are
4 Evaluating subjects with Possible PCOS
The cohort of participants who initially meet clinical features suggestive of PCOS ie HA OA or PCOM will be designated as Possible PCOS and will undergo the following measurements in their samples
1 In all Possible PCOS subjects TSH prolactin PRL and 17-HP will be measured in the basal serum samples as well as fasting glucose
Note All subjects diagnosed with PCOS should have a normal TSH PRL and 17-HP basally or after acute ACTH stimulation
2 In women presenting clinically with HAOA if the TV-US performed demonstrates PCOM the subject is classified as having PCOS phenotype A HAOAPCOM if not the subject is classified as having PCOS phenotype B HAOA
3 Subjects presenting clinically with HA only will return during the luteal phase days 21-24 of their menstrual cycle for a serum progesterone P4 level Subjects with HA who demonstrate OA ie luteal P4 3 ngmL will be classified as having PCOS phenotype A if they have PCOM by TV-US HAOAPCOM or PCOS phenotype B HAOA if they do not exhibit PCOM HA subjects who also demonstrate PCOM but no OA ie luteal P4 3 ngmL will be classified as PCOS phenotype C Participants with HA but no PCOM or OA will be classified as having isolated HA
4 Subjects presenting clinically with OA only their basal serum samples will be assayed for androgen levels total TT and free testosterone FT dehydroepiandrosterone sulphate DHEAS and androstenedione A4 Subjects with OA who demonstrate HA ie elevated androgen levels will be classified as having PCOS phenotype A if they have PCOM by TV-US HAOAPCOM or PCOS phenotype B HAOA if they do not exhibit PCOM OA subjects who also demonstrate PCOM but no HA ie normal androgen levels will be classified as PCOS phenotype D Participants with OA but no PCOM or HA will be classified as having isolated OA
5 Subjects presenting with PCOM by TV-US will return during the luteal phase days 22-24 of their menstrual cycle for a serum progesterone P4 level and their basal serum samples will be assayed for androgen levels total TT and free testosterone FT dehydroepiandrosterone sulphate DHEAS and androstenedione A4 Subjects with PCOM who demonstrate OA ie luteal P4 3 ngmL will be classified as having PCOS phenotype D If they also demonstrate HA ie elevated androgen levels HAOAPCOM will be classified as having PCOS phenotype A PCOM subjects who also demonstrate HA but no OA ie luteal P4 3 ngmL will be classified as PCOS phenotype C Participants with PCOM but no HA or OA will be classified as having isolated PCOM
5 Diagnosing PCOS
Related or mimicking disorders will be excluded using history physical examination and serum TSH PRL and 17-OHP Study participants with a basal 17-OHP 2 ngml or 200 ngdl will undergo a repeat 17-OHP measurement in the follicular phase and if the 17-OHP is still 2ngmL an acute adrenocorticotrophic hormone ACTH stimulation test will be performed to exclude non-classical congenital adrenal hyperplasia NCAH We estimate considering our previous data that approximately 6 of subjects screened will require an acute ACTH stimulation test
Overall PCOS will be diagnosed when subjects present with either HAOAPCOM phenotype A HAOA phenotype B HAPCOM phenotype C and OAPCOM phenotype D and demonstrate normal levels of TSH 037 to 47 mUIL PRL 25 ngmL and 17-OHP per our diagnostic algorithm
6 Evaluation visit 2
In the following cases subjects will be rescheduled for a second evaluation visit evaluation visit 2 for additional assessment
1 All subjects with PCOS will be scheduled for a return visit to undergo a 2-hour 75g oral glucose tolerance test OGTT with 3 ml of venous blood collected in serum tubes at 0 minutes and at 120 minutes post-glucose load Glucose and insulin from serum tubes levels will be assessed at 0 and 120 min
2 Participants will be reevaluated during the follicular phase of the menstrual cycle between day 1 and 5
i With a repeat ultrasound in case there is a dominant follicle 10 mm or an ovarian cyst at the initial ultrasound evaluation
ii A repeat 17-hydroxyprogesterone 17-OHP measurement in the event the initial 17-OHP is 2 ngmL and was obtained during the luteal phase according to menstrual history Approximately 50 of Participants evaluated in luteal phase are expected to have a 17-OHP 2 ngmL
iii An acute intravenous iv ACTH-1-24 025 mg stimulation test if the initial and repeat 17-OHP obtained during the follicular phase according to menstrual history is 2 ngmL
7 Reassessing hormonal levels
At the completion of the study a repeat analysis of the samples for androgen levels in all PCOS subjects and a group of super-controls 30 controls will be performed at a reference laboratory A fasting glucose level also be analyzed in a group of super controls 100 controls Genetic analysis could be performed depending on the availability of financial support in a reference laboratory
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None