Polycystic Ovary Syndrome Clinical Trial
Official title:
Laparoscopic Ovarian Drilling Versus Gonadotrophins for Anovulatory Polycystic Ovary Syndrome Resistant to First Line Ovulation Induction: a Randomized Controlled Trial.
PCOS is a complex disease that is diagnosed by the presence of two of the following three:
oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by
ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is
abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by
treatment.
Different treatment modalities are present for ovulation induction. Life style modifications
including weight loss are encouraged for those who are overweight or obese. Pharmacological
induction of ovulation represent the first line therapy for induction of ovulation. Options
include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in
combinations.
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are
the recommended options .
the objective of the trial is to study the effectiveness and safetey of surgical induction of
ovulation strategy and compare it to medical induction strategy with Gonadotropins
PCOS is a complex disease that is diagnosed by the presence of two of the following three:
oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by
ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is
abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by
treatment.
Different treatment modalities are present for ovulation induction. Life style modifications
including weight loss are encouraged for those who are overweight or obese. Pharmacological
induction of ovulation represent the first line therapy for induction of ovulation. Options
include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in
combinations.
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are
the recommended options .
Systematic reviews done comparing LOD to Gn found no differences in live birth, clinical
pregnancy or miscarriage rates. However, there was significant decrease in OHSS and multiple
pregnancies with LOD . Giving these advantages together with being cheap, the surgical
strategy may be a more favorable choice as second line treatment of anovulation . Also
several randomised controlled trial (RCTs) reported normalization of ovarian reserve
parameters after LOD, making it a long-lasting option compared to the one-cycle effect of
medical treatment the objective of the trial is to study the effectiveness and safetey of
surgical induction of ovulation strategy and compare it to medical induction strategy with
Gonadotropins
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