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Treatment guid line 2018 PCOD Treatment by Dr Sharda Jain Dr Jyoti Agarwal
1. TREATMENT
+
What we have learnt in last 50 years
International Guidelines 2018
DR SHARDA JAIN
DR JYOTI AGARWAL
…Caring hearts, healing hands
2. OBJECTIVES OF PPT PRESENTATION
• How we have evolved about PCOD TREATMENT
in last 50 years.
• 2018 INTERNATIONAL EVIDENCE BASED
GUIDELINES ,s have added to few more Best
Practices in the MANAGEMENT OF PCOD..& bcz
they are evidence based
NO CONTROVERSY
NO DOUBT
3. • most common endocrine disorder diagnosed in females in Reproductive years.
• It affects 3-20% & 70 % remain undiagnosed .
• PCOS-presents with variety of symptoms that can remit or relapse over time.
• These include; irregular or no menses, menorrhagia, excess facial and/or body
hair, infertility, patches of thick darker velvety skin, Central obesity, difficulty
losing weight (due to insulin resistance).
• Associated conditions include; Type 2 Diabetes , obstructive sleep apnoea, mood
disorders, and endometrial cancer.
• Other Metabolic sequelae include; hypertension, dyslipidaemia, visceral obesity,
insulin resistance, Hyperinsulinaemia and CHD.
OVERVIEW
5. PEARLS OF WISDOM
gained in the
Treatment of PCOD
1970-2018:
What have we learned about PCOD TREATMENT over the last 50 years?
•PCOS has no cure.
•Treatment involves lifestyle changes such as weight loss and exercise.
•The OCP may help improving the regularity of periods, excess hair growth, and acne.
•Metformin and anti-androgens may also help.
•Other typical acne treatments and hair removal techniques may be used.
•Efforts to improve fertility include weight loss, ovulation induction (e.g. clomiphene),
or metformin and IVF is used by some in whom other measures are not effective.
•Laparoscopic ovarian drilling may be helpful in resistant cases or where hormonal
therapy is contra-indicated or associated with severe side effects.
•Fertility therapy with PCO is associated with an increased risk OHSS.
•Untreated patients are at higher risk fo metabolic syndrome and endometrial cancer.
9. Lifestyle &
Is All About Diet, Exercise & Attitude
Psychosocial depression, sexual and quality of life scoring ,
eating disorders if any should be evaluated and managed.
LIFE Style modifications are most important component of
Treatment .
Lifestyle intervention (including nutritious Diet, regular
exercise and good behavioural habits & strategies) should
be recommended in all those with PCOS and excess weight,
for
reductions in weight, central obesity
and insulin resistance.
10. Lifestyle
Achievable goals such as 5% to 10% weight
loss in those with excess weight yields
significant clinical improvements.
11. Daily moderate exercise for 40 – 60 min
improves body's use of insulin and can help
relieve symptoms of PCOS
Running/Jogging
Chakki Chalanasana
12. Treatment PCOS:
What we learnt so far !
• Therapeutic approaches for adult patients not seeking fertility include
COMBINED ORAL CONTRACEPTIVES (COC), ANTIANDROGENS (AA) AND/OR
INSULIN SENSITIZERS (metformin ), although these practices are supported by
limited high-quality evidence.
• METANALYSIS PUBLISHED HUMAN REPRODUCTION 2017: COC versus AA versus
Metformin alone or in combination for the treatment of PCOS. Outcome
measures included hirsutism scores, IR, BMI, menses pattern, BP, lipid profile,
GTT.
• COC and AA are more effective than METFORMIN for Hyperandrogenic
symptoms and Endometrial protection. Their combination with Metformin adds
a positive effect on BMI and glucose tolerance.
13. Menstrual disorders :Combined oral
contraceptive pill (COCP)
containing non-androgenic progesterone
For ACNE/ HIRSUITISM - Ethiny Estradiol + anti
Androgen Cyproternoe Acetate
(Diane 35 / Krimson 35) was prescribe till now.
Non-fertility indications in ADOLESCENTS
Hyperandrogenism + Irregular Periods
what we have been doing so far
14. Pharmaceutical treatment for non-fertility
indications in ADOLESCENTS
Hyperandrogenism + Irregular Periods
2018 Guidelines
• The COCP could be considered in adolescents who are deemed
“at risk” but not yet diagnosed with PCOS by ULTRASOUND,
for management of clinical Hyperandrogenism and irregular
menstrual cycles (3/2)
• The 35 microgram ethinyloestradiol plus cyproterone acetate
preparations should Not be considered first line in PCOS as per
guidelines, due to adverse effects including
VENOUS THROMBOEMBOLIC risks.
15. Non-fertility indications
In ADULT WOMEN as per 2018 Guidelines
• The COCP alone should be recommended in adult
women with PCOS for management of
hyperandrogenism and/or irregular menstrual
cycles. (4/2)
16. • The COCP alone should be considered in
adolescents with a clear diagnosis of PCOS
for management of clinical
hyperandrogenism and/or irregular
menstrual cycles. 3/2
Pharmaceutical treatment for non-fertility
indications in ADOLESCENTS
Hyperandrogenism + Irregular Periods
2018 Guidelines
17. COCPin combination with METFORMIN
in adult women
• In combination with the COCP,
metformin should be considered in
women with PCOS for management of
metabolic features where COCP and
lifestyle changes do not achieve desired
goals.( 4/2)
18. COCP in combination with Metformin
and/or Anti-androgen in ADOLESCENTS
In combination with the COCP, Metformin could be
considered in Adolescents with PCOS and BMI ≥
25kg/m2 ( OVER WEIGHT ) where COCP and lifestyle
changes do not achieve desired goals (4/2)
In combination with the COCP, Metformin may be
most beneficial in high METABOLIC risk groups
including those with DIABETES risk factors, impaired
glucose tolerance or high-risk ethnic groups ( 4/2)
19. ANTIANDROGENS
Adolescents / ADULT WOMEN
• In combination with the COCP, ANTIANDROGENS
should only be considered in PCOS to treat
HIRSUTISM, after six months or more of COCP and
cosmetic therapy have failed to adequately improve
symptoms .(2/2)
• In combination with the COCP,ANTIANDROGENS
could be considered for the treatment of Androgen-
related ALOPECIA in PCOS. 2
21. PCOS and Metformin:
Our understanding so far !
• Metformin was logically introduced to establish the extent to which
hyperinsulinaemia influences the pathogenesis of PCOS.
• Early studies were very encouraging but RCTs and several meta-analyses
have changed the picture.
• In PCOS failure of the target cells to respond to normal or ordinary levels of
insulin is regarded as insulin resistance (IR).
• IR leads to a compensatory increased production of insulin by the pancreatic
beta cells to control the hyperglycaemia which ultimately fails leading to
T2DM.
• In PCOS, hyperinsulinaemia has been thought to increase
hyperandrogenaemia via a central role or by decreasing the circulating levels
of SHBG.
• IR is not considered a diagnostic criterion in PCOS. However, it is
recognized by many as a common feature in PCOS independent of obesity
22. Metformin: Our Understanding
• Metformin improves sensitivity of peripheral tissues to insulin reducing serum
levels.
• Metformin inhibits hepatic gluconeogenesis and it also increases the glucose uptake by
peripheral tissues and reduces fatty acid oxidation.
• Metformin has a positive effect on the endothelium and adipose tissue independent of
its action on insulin and glucose levels.
• Main side effects are GI; nausea, diarrhoea, flatulence, bloating, anorexia, metallic taste
and abdominal pain. These symptoms occur with variable degrees in patients and in
most cases resolve spontaneously.
• Start dose of 500 mg daily during the main meal of the day for 1–2 weeks can lessen
side effects and allow tolerance to develop. A weekly or biweekly increase by 500 mg a
day can then be pursued up to maximum 2500–2550 mg/day.
• slow release metformin can be associated with fewer side effects. Metformin can also
lead to vitamin B12 malabsorption in the distal ileum in approximately 10–30% of
patients which is an effect dependent on age, dose and duration of treatment.
23. Metformin in PCOS:Our Understanding so far
• Metformin works by reducing the circulating insulin levels.
• Conflicting evidence as to whether it can directly affect ovarian steroidogenesis.
• May restore ovulation, reduce weight, reducing circulating androgen levels, reducing the
risk of miscarriage and reducing the risk of gestational diabetes mellitus (GDM).
• Other studies have reported that the addition of metformin to the ovarian stimulation
regime in in vitro fertilization (IVF) improves the pregnancy outcome.
•
24. Metformin in PCOS:Our Understanding so far
• The lack of an emphatic or overwhelming efficacy for Metformin in females with PCOS is
largely due to the patients' variability in phenotypes and their metabolic parameters.
Some studies have tried to identify the patients that are most likely to benefit from
metformin, yet again the results have not been forthcoming.
• Metformin does not replace the need for lifestyle modification among obese and
overweight PCOS women. The evidence categorically does not encourage its use to help
weight loss either although it may be useful in redistributing adiposity according to some
evidence.
• The long-term use of Metformin to prevent remote complications of PCOS is uncertain
and a significant amount of work is needed before a decision can be made on this front.
Stipulations from studies carried out on the general population is not the same and can
be misleading given the diversity of PCOS patients with regard to their metabolic
comorbidities.
•
25. METFORMIN + Lifestyle
2018 Guidelines
• Metformin in addition to lifestyle, could be
recommended in adult women with PCOS, for the
treatment of weight, hormonal and metabolic
outcomes. 3/2
BMI ≥ 25kg /m2 ( indian -2.5)
26. METFORMIN In adolescents
2018 Guidelines
• Metformin in additional to lifestyle, could be
considered in ADOLESCENTS with a clear diagnosis
of PCOS or with symptoms of PCOS before the
diagnosis is made. 3/2
• Metformin may offer greater benefit in high
metabolic risk groups including those with diabetes
risk factors, impaired glucose tolerance or high-risk
ethnic groups
27. Prescribing METFORMIN-2018
GUIDELINES
Where metformin is prescribed the following need to be
considered:
Adverse Effects, including gastrointestinal side-effects that
are generally dose dependent and self-limiting, need to be
the subject of individualised discussion
Starting at a Low Dose, with 500mg Increments 1-2 weekly
and extended release preparations may minimise side effects
metformin use appears long-term safe, based on use in
other populations,
however ongoing requirement needs to be considered and use
may be associated with low vitamin B12 levels
28. ANTI-ANDROGEN
2018 GUIDELINES
• Where COCPs are contraindicated or poorly
tolerated, in the presence of other effective forms
of contraception, anti-androgens could be
considered to treat HIRSUTISM and androgen-
related ALOPECIA. 3/1
• Specific types or doses of Antiandrogens cannot
currently be recommended with inadequate
evidence in PCOS.
29. INOSITOL
2018 GUIDELINES
• Inositol (in any form) should currently be
considered an experimental therapy in PCOS,
with emerging evidence on efficacy highlighting
the need for further research. 1/1
31. As little as 5% of initial weight loss
over 6 months improves
fertility outcome
32. FIRST LINE
LETROZOLE
SECOND LINE
LOD/GONADOTROPINS
THIRD LINE
IVF
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2007 ESHRE/ASRM-Sponsored PCOS Consensus
Workshop ,
2018 Guidelines are more or less the same except
very minor changes.
33. Assessment and treatment of
INFERTILITY (2018 Guidelines)
• Factors such as blood glucose, weight, blood
pressure, smoking, alcohol, diet, exercise,
sleep and mental, emotional and sexual
health need to be optimised in women with
PCOS, to improve reproductive and
obstetric outcomes, aligned with
recommendations in the general
population.
34. Assessment and treatment of infertility
(2018 Guidelines)
• Monitoring during pregnancy is important
in women with PCOS, given increased risk of
adverse maternal and offspring outcomes.
• Tubal patency testing should be considered
prior to ovulation induction in women with
PCOS where there is suspected tubal
infertility.
35. Ovulation Induction Principles
2018 Guidelines
• The use of ovulation induction agents, including
Letrozole, Metformin And Clomiphene Citrate is off
label in many countries.
• Where off label use of ovulation induction agents is
allowed, health professionals need to inform
women and discuss the evidence, possible concerns
and side effects.
36. LETROZOLE in PCOD
2018 Guideline
• Letrozole should be considered FIRST LINE
pharmacological treatment for ovulation induction
in women with PCOS with ANOVULATORY
INFERTILITY and no other infertility factors to
improve ovulation, pregnancy and live birth rates.
• Health professionals and women need to be aware
that the risk of multiple pregnancy appears to be
less with Letrozole, compared to Clomiphene
citrate.
37. Clomiphene citrate and Metformin
2018 Guidlines
• Clomiphene citrate could be used alone in women with PCOS with
anovulatory infertility and no other infertility factors to improve
ovulation and pregnancy rates.3/1
• Metformin could be used alone in women with PCOS, with
anovulatory infertility and no other infertility factors, to improve
ovulation, pregnancy and live birth rates, although women should
be informed that there are more effective ovulation induction
agents. 3/3
• Clomiphene citrate could be used in preference, when considering
clomiphene citrate or metformin for ovulation induction in women
with PCOS who are obese (BMI is ≥ 30 kg/m2) with anovulatory
infertility and no other infertility factors
38. Clomiphene citrate + metformin
2018 Guidelines
• If Metformin is being used for ovulation induction in women
with PCOS who are obese (BMI ≥ 30kg/m2) with anovulatory
infertility and no other infertility factors, clomiphene citrate
could be added to Metformin to improve ovulation,
pregnancy and live birth rates.3/2
• Clomiphene citrate could be combined with
metformin, rather than persisting with clomiphene citrate
alone, in women with PCOS who are CLOMIPHENE CITRATE-
RESISTANT, with anovulatory infertility and no other
infertility factors, to improve ovulation and pregnancy
rates.3/2
39. 2018 Guidelines
Gonadotrophins
Gonadotrophins could be used AS SECOND LINE
pharmacological agents in women with PCOS who have
failed first line oral ovulation induction therapy and are
anovulatory and infertile, with no other infertility factors.
With USG monitoring with cost and multiple pregnancies
explained.
Either gonadotrophins or laparoscopic ovarian surgery could
be used in women with PCOS with Anovulatory infertility,
clomiphene citrate-resistance and no other infertility
factors, following counselling on benefits and risks of each
therapy
40. LOD :HISTORY /Rationale:
• Laparoscopic drilling for PCOS was first used 1984 involving
multiple micro-perforations of the ovarian surface via diathermy
or LASER destroying ovarian stroma and peripheral follicles of
PCOS.
• Punctures ovarian cortex 4–10 mm deep/3 mm wide and number
of punctures related to subsequent ability to conceive. 5-10
punctures more likely to produce conception.
• Use monopolar needle/hook and electrocoagulation at 40 W,
(range from 30-400 W). Laparoscopic approach < morbidity then
ovarian wedge resection.
• Aims to reduce the amount of androgen producing tissue, may
reduce circulating E2 levels, LH level/pulsations, and inhibin B.
• The most plausible theory is that reduction of these leads to an
increase in the secretion of FSH and SHBG leading to effective
follicular maturation and ovulation.
• Low serum E2 associated with <aromatase activity. IGF-1
produced with injury aids effects of FSH through greater blood
flow GnRH delivery. AMH levels fall after drilling
• Goal of drilling treatment is induction of mono-ovulatory cycles.
THEN
NOW
41. • Weight loss and Clomiphene Citrate (CC) first line therapy.
• CC is a Selective Estrogen Receptor Modulator (SERM) with;
49% ovulation rate, 30% pregnancy rate, 23% live birth rate at
6 months, and 8% rate of multiple gestation.
• Other non-surgical PCOS medical therapy options include; the
SERM Tamoxifen or aromatase inhibitors, insulin sensitising
drugs, and hormonal ovarian stimulation.
• 25% women are resistant to CC therapy
• CC therapy is followed by GnRH therapy but >risk OHSS
• Laparoscopic drilling may reduce the risk of OHSS
• The effectiveness of the surgical procedure is similar to CC but
results in fewer multiple pregnancies per ongoing pregnancy
regardless if the technique is unilaterally or bilaterally
performed
• If patients do not become pregnant 6 months after ovulation is
induced by ovarian drilling then GnRH therapy and IVF
warranted
LOD :HISTORY /Rationale:
A strategy of
minimizing
the number
of diathermy
points to:
4/ovary
For 4 s
At 40 W
(Armar et al. Fertil Steril
1990;53:45–9
Rule of 4
42. Laparoscopic ovarian drilling
2018 Guidlines
Laparoscopic ovarian surgery could be second line therapy
for women with PCOS, who are clomiphene citrate resistant,
with anovulatory infertility and no other infertility
factors.3/2
Laparoscopic ovarian surgery could potentially be offered as
FIRST LINE TREATMENT if laparoscopy is indicated for
another reason in women with PCOS with Anovulatory
infertility and no other infertility factors.
43. Laparoscopic ovarian drilling
2018 Guideline
intra-operative and post-operative risks are
higher in women who are overweight and
obese
there may be a small associated risk of lower
ovarian reserve or loss of ovarian function
Periadnexal adhesion formation may be an
associated risk.
44. In-vitro fertilisation (IVF)
2018 Guideline
• In the absence of an absolute indication for IVF ±
intracytoplasmic sperm injection (ICSI), women with PCOS
and Anovulatory infertility could be offered IVF as third line
therapy where first or second line ovulation induction
therapies have failed.
• In women with ANOVULATORY PCOS, the use of IVF is
effective and when elective single embryo transfer is used
multiple pregnancies can be minimised.
45. In-vitro fertilisation (IVF)
2018 Guideline
Women with PCOS undergoing IVF ± ICSI therapy need to be
counselled prior to starting treatment including on:
● Availability, cost and convenience
● Increased risk of ovarian hyperstimulation syndrome
● options to reduce the risk of ovarian hyperstimulation.
46. FIRST LINE
Letrozole
SECOND LINE
LOD/GONADOTROPINS
THIRD LINE
IVF
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TAKE HOME MESSAGES
2018 GUIDELINES ON PCOD .
INFERTILITY GUIDELINE TO BE FOLLOWED WORLD OVER
CC
Metformin
47. ADDRESS
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Karkari Morh Flyover,
Delhi - 51
CONTACT US
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