TRAZER STUDY 2021

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.

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