TRAZER
STUDY
Safety & Efcacy Of The Combination Therapy Of Inositols, Antioxidants And Vitamins In Polycystic Ovarian Syndrome (PCOS): A Multicentric, Retrospective Observational Study (Trazer Study)
ESHRE Virtual 37th Annual Meeting 2021 26 June - 1 July
TRUST THAT GET STRONGER WITH EVIDENCE ENDORSEMENT EXPERIENCE
In PCOS, Right Choice at Right Time
TRAZER STUDY Study Synopsis Safety & Efcacy Of The Combination Therapy Of Inositols, Antioxidants And Vitamins In Polycystic Ovarian Syndrome (PCOS): A Multicentric, Retrospective Observational Study (Trazer Study)
Study type: Multicentric retrospective observational study at 36 fertility clinics in different states of India (n=180)
Patients Obese & Lean PCOS Women
Intervention
Dosage 1 TAB BID for 3-6 Months from the day of diagnosis Ref. ESHRE Virtual 37th Annual Meeting 2021; P 686; 26 June - 1 July
Signicant Improvement In Clinical Symptoms : Acne, Hirsutism OBESE WOMEN WITH PCOS
44.50% reduction in Acne 51.69% reduction in Hirsutism
20 18
-44.50%
16 14
-23.77%
12 10 8
-51.69%
6
-23.73%
4 2 0
Before
Acne
After 3 months
Hirsutism
After 6 months
Fig 1: Various Clinical Symptoms : Acne, Hirsutism - Before and after intervention of Trazer F ForteTM in obese women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Clinical Symptoms : Acne, Hirsutism LEAN WOMEN WITH PCOS
39.60% reduction in Acne
20
43.20% reduction in Hirsutism
18 16
-39.60%
14 12
-13.84%
10 8 6
-43.20%
4 -24.21%
2 0
Acne
Before
After 3 months
Hirsutism
After 6 months
Fig 2: Various Clinical Symptoms : Acne, Hirsutism - Before and after intervention of Trazer F ForteTM in lean women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Ovarian Parameters: No Of Cysts, Size Of Cyst, Cysts Dissolution, Reduced Cyst Size OBESE WOMEN WITH PCOS
48.98% reduction in Number of Cysts
100
-74.60%
90
-56.10%
26.30% reduction in Complete Cyst Dissolution
80 70 60
-48.98%
-38.44% -26.30%
50 40
38.44% reduction in Size of Cysts
-21.13%
-16.87%
30
74.60% reduction in Cyst Size
-6.30%
20 10 0
Before
Number of cysts
After 3 months
Size of cysts (mm)
Complete cyst dissolution (% Patients)
Reduced Cyst size (% Patients)
After 6 months
Fig 3: Various Ovarian Parameters: No Of Cysts, Size Of Cyst Etc, Cysts Dissolution, Reduced Cyst Size - Before and after intervention of Trazer F ForteTM in obese women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Ovarian Parameters: No Of Cysts, Size Of Cyst, Cysts Dissolution, Reduced Cyst Size LEAN WOMEN WITH PCOS
35.20% reduction in Number of Cysts 25.80% reduction in Size of Cysts
100 90 80 70 60
-36.10% -35.20%
-25.80%
-32.20%
-25.00%
50 40
25.00% reduction in Complete Cyst Dissolution
-21.39%
-16.13%
30
36.10% reduction in Cyst Size
-11.20%
20 10 0
Before
Number of cysts
After 3 months
Size of cysts (mm)
Complete cyst dissolution (% Patients)
Reduced Cyst size (% Patients)
After 6 months
Fig 4: Various Ovarian Parameters: No Of Cysts, Size Of Cyst Etc, Cysts Dissolution, Reduced Cyst Size - Before and after intervention of Trazer F ForteTM in lean women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Metabolic Parameters: Fasting Glucose, Fasting Insulin, HOMA Index, BMI, Body Weight, Waist Circumference OBESE WOMEN WITH PCOS
17.30% reduction in Fasting Glucose -5.77%
-17.30% -11.23%
-4.05%
100
-2.11%
90
34.19% reduction in HOMA Index
-2.11%
80
-3.71%
-19.94%
70 60
40
3.71% reduction in BMI
-2.26%
-13.25%
50
4.05% reduction in Body Weight
-34.19%
30
-22.95%
20
5.77% reduction in Waist Circumference
10 0
19.94% reduction in Fasting Insulin
Fasting glucose (mg/dL)
Before
Fasting insulin (mIU/mL)
After 3 months
HOMA index
BMI (kg/m2)
Body weight (kg)
Waist circumference (cm)
After 6 months
Fig 5: Various Metabolic Parameters: Fasting Glucose, Fasting Insulin, Homa Index, BMI, Body Weight, Waist Circumference - Before and after intervention of Trazer F ForteTM in obese women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Metabolic Parameters: Fasting Glucose, Fasting Insulin, HOMA Index, BMI, Body Weight, Waist Circumference LEAN WOMEN WITH PCOS
13.40% reduction in Fasting Glucose -2.20%
-13.40% -5.18%
-0.80%
100
-1.19%
90
21.60% reduction in HOMA Index
-0.14%
80
-0.10%
-14.40%
70 60
40
0.10% reduction in BMI
-0.19%
-10.41%
50
0.80% reduction in Body Weight
-21.60%
30
-15.74%
20
2.20% reduction in Waist Circumference
10 0
14.40% reduction in Fasting Insulin
Fasting glucose (mg/dL)
Before
Fasting insulin (mIU/mL)
After 3 months
HOMA index
BMI (kg/m2)
Body weight (kg)
Waist circumference (cm)
After 6 months
Fig 6: Various Metabolic Parameters: Fasting Glucose, Fasting Insulin, Homa Index, BMI, Body Weight, Waist Circumference - Before and after intervention of Trazer F ForteTM in lean women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Hormonal Parameters: LH : FSH Ratio, Progesterone, AMH, Free Testosterone OBESE WOMEN WITH PCOS
37.96% reduction in LH:FSH Ratio 19.19% reduction in AMH
50 45
-51.13%
40 35
51.13% reduction in Free Testosterone
-40.37%
30 25 20 15
***
-37.96% -19.44%
***
-19.19% -13.52%
10 5 0 LH:FSH ratio
Before
After 3 months
Progesterone (ng/mL)
AMH (ng/mL)
Free testosterone (pmol/L)
After 6 months
Fig 7: Various Hormonal Parameters: LH : FSH Ratio, Progesterone, AMH, Free Testosterone - Before and after intervention of Trazer F ForteTM in obese women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Hormonal Parameters: LH : FSH Ratio, Progesterone, AMH, Free Testosterone LEAN WOMEN WITH PCOS
33.20% reduction in LH:FSH Ratio 27.50% reduction in AMH
50 45
27.00%
40 35
25 20 15
-19.14%
***
30
27.00% reduction in Free Testosterone
***
-27.50%
-33.20%
-8.08% -22.12%
10 5 0 LH:FSH ratio
Before
After 3 months
Progesterone (ng/mL)
AMH (ng/mL)
Free testosterone (pmol/L)
After 6 months
Fig 8: Various Hormonal Parameters: LH : FSH Ratio, Progesterone, AMH, Free Testosterone - Before and after intervention of Trazer F ForteTM in lean women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Reproductive Outcome: Ovulation & Clinical Pregnancy Rate OBESE WOMEN WITH PCOS
100
88.20% improvement in Ovulation
88.20%
90
34.10% improvement in Clinical Pregnancy Rate
80 70
54.30%
60 50 40
34.10%
30
16.20%
20 10 0
Ovulation
0% Before
After 3 months
After 6 months
Clinical pregnancy (% patients)
Fig 9: Various Reproductive Outcome: Ovulation & Clinical Pregnancy Rate - Before and after intervention of Trazer F ForteTM in obese women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Signicant Improvement In Reproductive Outcome: Ovulation & Clinical Pregnancy Rate LEAN WOMEN WITH PCOS
79.50% improvement in Ovulation 22.10% improvement in Clinical Pregnancy Rate
100 90
79.50%
80 70 60
48.70%
50 40 30
22.10%
20 10 0
Ovulation
9.90% 0% Before
After 3 months
After 6 months
Clinical pregnancy (% patients)
Fig 10: Various Reproductive Outcome: Ovulation & Clinical Pregnancy Rate - Before and after intervention of Trazer F ForteTM in lean women with PCOS after 3 and 6 months intervention. The data are represented as mean ± SEM or percentage. The data were analysed by one-way ANOVA followed by post-hoc Bonferroni’s multiple comparison test. *P<0.05, **P<0.001 vs. respective baseline.
Manages PCOS at all levels Peroxidation Increased GnRH pulse frequency
Pituitary Gland
ROS & Cytokines
Oxidative stress
Adipose Tissue
Pancreas
Progesterone
Acne
NAC & Lycopene
AGEs Biotin & Chromium
Central Obesity
Vitamin D LH
Hyperandrogenism
Hyperinsulinemia
Hyperandrogenism
Insulin
MI DCI
Liver
Hirsutism
LH:FSH
Hyperglycemia
PPA Ry
FSH
Glucose
Insulin Receptor
SHBG
DHEAS Adrenal gland
With LH ion
Granulosa Cells
Multiple cysts Irregular menstrual cycles
AMH
Androgen
MI
Epimerase
DCI
n Tra
DCI-IPG MI:DCI Imbalance
PI3 K
Progesterone
UT GL
4
Glucose utilization
MI
Estrogen Oligo/Anovulation
Glucose Uptake
IRS
DCI Epimerase
Aromatase
cat
slo
Theca Cells
Folate
Glycogen
MI:DCI 40:1
Correction
Activation
Reduction
Fig 11: Schematic representation of the mechanism of action of MI:DCI 40:1 ratio, NAC, lycopene, Chromium, Vitamin D3, biotin and folic acid in Trazer F ForteTM
Manages PCOS at all levels
Conclusion Combination of inositols, antioxidants and vitamins can be used as a promising and clinically relevant non-hormonal treatment option for women with PCOS for satisfactory clinical outcomes.
Ref. ESHRE Virtual 37th Annual Meeting 2021; P 686; 26 June - 1 July
In PCOS / PCOD
(Myo-Inositol + D-Chiro-Inositol) 600 mg + N-Acetyl Cysteine 300 mg + Biotin 30 mcg + Lycopene 10% 5 mg + Chromium 200 mcg + Folic Acid 120 mcg + Vitamin D 400 IU Tablets
st D 1 BRAN 1
Manages PCOS at all levels
Evidences1,2,3 International Publication
Journal of
Obstetrics and Gynaecology
1,2,3
Studies
TRAZER Study, ROSE Study & EETOP Study at different fertility centres in India
th
ESHRE Virtual 37 Annual Meeting 2021 26 June - 1 July th
The 28 World Congress on Controversies in Obstetrics, Gynecology, & Infertility (COGI) Berlin, Germany, November 19-21, 20202
Efcacy of combination therapy of inositols, antioxidants and vitamins in obese and non-obese women with polycystic ovary syndrome Multi-centric study conducted at 11 centres in India Volume 40
Issue 1
January 2020
Experience > 3500 fertility specialist since 8 years
1. Abstract P21-0776, ESHRE Virtual 37th Annual Meeting 2021, 26 June - 1 July. 2. Abstract 145, The 28th World Congress on Controversies in Obstetrics, Gynecology, & Infertility (COGI), Berlin, Germany, November 19-21, 2020 3. J Obstet Gynaecol. 2020 Jan;40(1):96-101. Disclaimer : The views, opinion, ideas etc expressed herein are solely those of the author. Corona Remedies Pvt. Ltd. does not certify the accuracy, completeness, currency of any information and shall not be responsible or in anyway liable for any errors, omissions or inaccuracies in such information. Corona Remedies Pvt. Ltd. is not liable to you in any manner whatsoever for any decision made or action or nonaction taken by you in reliance upon the information provided. Corona Remedies Pvt Ltd does not recommend the use of its products in unapproved indications and recommends to refer the complete prescribing information prior to using any of the Corona Remedies Pvt. Ltd. products.