PCOS Clinical Trial
Official title:
Clomiphene Citrate Plus N-acetyl Cysteine Versus Clomiphene Citrate for Induction of Ovulation in Women With Newly Diagnosed Polycystic Ovary Syndrome: a Randomized Double-blind Controlled Trial
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders, affecting
approximately 6-10% of women of reproductive age. Anovulation, infertility and
hyperandrogenism often co-exist with hyperinsulinaemia and insulin resistance .
Clomiphene citrate remains the standard drug for induction or augmentation of ovulation.
However, it is not equally effective in all situations, and therefore it may require
additional expensive drugs such as N-acetyl cysteine, as an antioxidant, has been suggested
as an adjuvant in clomiphene-resistant cases .NAC may also improve the circulating level of
insulin and insulin sensitivity in hyperinsulinaemic women with PCOS, and may be useful for
the treatment of insulin resistance by ameliorating the homocysteine and lipid profile in
PCOS .
NAC has been used effectively as an adjuvant to clomiphene citrate (CC) for ovulation
induction in CC-resistant women with PCOS .
Because it is an insulin sensitizer, NAC was proposed as an adjuvant to clomiphene citrate
for ovulation induction in patients with polycystic ovary syndrome who are resistant to
clomiphene citrate. Encouraging results in those patients stimulated us to investigate
whether adding NAC to the standard treatment with CC results in a higher ovulation rate,
higher pregnancy rate, and less CC resistance in women with newly diagnosed polycystic ovary
syndrome using a randomized, double-blind, controlled study.
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