TRAZER STUDY 2021

Page 1

TRAZER

STUDY

Safety & Efcacy 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 & Efcacy 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


Signicant 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.


Signicant 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.


Signicant 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.


Signicant 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.


Signicant 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.


Signicant 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.


Signicant 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.


Signicant 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.


Signicant 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.


Signicant 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

Efcacy 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.


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.