NCT01896492

Clomiphene Plus N-acetyl Cysteine for Induction of Ovulation in Newly Diagnosed Pcos.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Woman's Health University Hospital, Egypt · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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 .

Detailed description

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.

Conditions

• PCOS

Interventions

Type	Name	Description
DRUG	NAC	NAC 2gm plus cc 100mg from 3rd day of the cycle till day 8 with u/s follow up of the follicular growth.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-07-11
• Last updated: 2020-08-12