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Use & Abuse Of Infertility
Tests
Model of Endometrial receptivity
1
•Introduction
2
•Root causes
3
•How to combat ?
????
Evidence is clear
Since 2014
available data do not support an
association between aPL and
infertility, and aPL positivity does not
seem to influence IVF outcome.
ViT D assay
Beneficial
Impact of Inappropriate Lab Utilization
Financial Burden
Medical
Unnecessary blood draws
Phlebotomy acquired anemia
.
Increased Costs
Patient?
Center ?
Likelihood of false-positive
results
1
•Introduction
2
•Root causes
3
•How to combat ?
HSC
• Patient Pressure
Up to 50%
Fee incentive
TORCH for RPL
Lack of Knowledge
More is Safer
Defensive Medicine
Unusual Inv.
Business development
Does PGS help increase pregnancy rate in IVF?
1
7
Moniek Twisk et al., Hum Reprod; 20013
•
Cost-effectiveness analysis of PGS and IVF
versus expectant management in patients with
unexplained recurrent pregnancy loss
Unexplained RPL, IVF/PGS with 24-CCS (232)and
expectant management (302)
Main Outcomes Measure(s):Cost /LB.
Result(s): LBR and miscarriage were 53% and 7%.
IVF/PGS and 67% and 24% in expectant. PGS 100-fold
more expensive, $45,300/LB compared $418/LB with
expectant.
Conclusion(s):IVF/PGS not cost-effective.
LBR with IVF/PGS needs to be 91% to be cost
effective compared with expectant.
Murugappan, et al., Fertility Sterility, 2015
1
•Introduction
2
•Root causes
3
•How to combat ?
Practical Steps to combat the problem
Diagnostic
Algorithms
Evidence Based Cost
effectiveness
System
Approach
Abnormal sperm count
Normal sperm analysis, eugonadal
No tests are required Measure testosterone,
gonadotrophins, and Prolactin
Testosterone
Gonadotrophins
Testosterone
 Gonadotrophins
Testosterone
 Prolactin
Diagnostic approach for man
History & examination
Primary testicular failure
Hypogonadotrophic
hypogonadism: due to
hypothalamic-pituitary
disease
Hyperprolactinaemia: rare
History & Examination
Amenorrhoea, Oligomenorrhoea
Normal menses
?Ovulating
Measure [Progesterone] in day 21 (mid luteal)
Perform pregnancy
test
Further tests
indicated
+ ve
Measure [LH], [FSH], & [Prolactin]
High FSH. (+ LH)
>30nmol/L <10nmol/L
Ovarian failure
Ovulating Not ovulating
No
further
tests
required
-ve
High LH
Low FSH
PCOS
High
Prolactin
Further investigate
hyperprolactinaemia
All Normal
Diagnostic approach to anovulatory woman
E.R can not be accurately predicted
Commercially available without evidence
the ERA test (Endometrial
Receptivity Array) :
a customized array based on the
expression of 238 genes coupled
to a computational predictor
capable of diagnosing a
functionally receptive
endometrium.(Diaz-Gimeno P et
al.,2011)
- Recurrent implantation failure
- Single embryo transfer (sET). (Barzilay Eran et al.,2018)
- endometrial biopsy must be performed at P+5 (hormone replacement
therapy cycle) or at LH+7 (natural cycle)
Invasive
But
• No RCT have been conducted
• Commercially propagated without clear
evidence
• Very expensive
Question
• Why to jump from research to practice
without evidence?
• Who pay for it ?
• Does it really improve pregnancy rate?
Let’s achieve More with Less

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Abuse

  • 1. Use & Abuse Of Infertility Tests Model of Endometrial receptivity
  • 5. Since 2014 available data do not support an association between aPL and infertility, and aPL positivity does not seem to influence IVF outcome.
  • 8.
  • 9. Impact of Inappropriate Lab Utilization Financial Burden Medical Unnecessary blood draws Phlebotomy acquired anemia . Increased Costs Patient? Center ? Likelihood of false-positive results
  • 12. Up to 50% Fee incentive
  • 13. TORCH for RPL Lack of Knowledge
  • 16.
  • 17. Does PGS help increase pregnancy rate in IVF? 1 7 Moniek Twisk et al., Hum Reprod; 20013
  • 18. • Cost-effectiveness analysis of PGS and IVF versus expectant management in patients with unexplained recurrent pregnancy loss Unexplained RPL, IVF/PGS with 24-CCS (232)and expectant management (302) Main Outcomes Measure(s):Cost /LB. Result(s): LBR and miscarriage were 53% and 7%. IVF/PGS and 67% and 24% in expectant. PGS 100-fold more expensive, $45,300/LB compared $418/LB with expectant. Conclusion(s):IVF/PGS not cost-effective. LBR with IVF/PGS needs to be 91% to be cost effective compared with expectant. Murugappan, et al., Fertility Sterility, 2015
  • 20. Practical Steps to combat the problem Diagnostic Algorithms Evidence Based Cost effectiveness System Approach
  • 21. Abnormal sperm count Normal sperm analysis, eugonadal No tests are required Measure testosterone, gonadotrophins, and Prolactin Testosterone Gonadotrophins Testosterone  Gonadotrophins Testosterone  Prolactin Diagnostic approach for man History & examination Primary testicular failure Hypogonadotrophic hypogonadism: due to hypothalamic-pituitary disease Hyperprolactinaemia: rare
  • 22. History & Examination Amenorrhoea, Oligomenorrhoea Normal menses ?Ovulating Measure [Progesterone] in day 21 (mid luteal) Perform pregnancy test Further tests indicated + ve Measure [LH], [FSH], & [Prolactin] High FSH. (+ LH) >30nmol/L <10nmol/L Ovarian failure Ovulating Not ovulating No further tests required -ve High LH Low FSH PCOS High Prolactin Further investigate hyperprolactinaemia All Normal Diagnostic approach to anovulatory woman
  • 23. E.R can not be accurately predicted
  • 24. Commercially available without evidence the ERA test (Endometrial Receptivity Array) : a customized array based on the expression of 238 genes coupled to a computational predictor capable of diagnosing a functionally receptive endometrium.(Diaz-Gimeno P et al.,2011)
  • 25. - Recurrent implantation failure - Single embryo transfer (sET). (Barzilay Eran et al.,2018) - endometrial biopsy must be performed at P+5 (hormone replacement therapy cycle) or at LH+7 (natural cycle) Invasive
  • 26. But • No RCT have been conducted • Commercially propagated without clear evidence • Very expensive
  • 27. Question • Why to jump from research to practice without evidence? • Who pay for it ? • Does it really improve pregnancy rate?
  • 28. Let’s achieve More with Less

Notas do Editor

  1. Example: If test probability is only 1% and the test is false positive result can mislead the diagnosis. Or Thyroid profiling in a ICU patient give false results.