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

Woman's Health University Hospital, Egypt

Status and phase: Completed; Phase 4

Conditions: PCOS

Treatments: Drug: NAC

Study type: Interventional

Funder types: Other

Identifiers

NCT01896492

ccpnacinovi

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PCOS diagnosed by Rotterdam's criteria

Exclusion criteria

• previous induction of ovulation male factoe infertility tubal factor infertility uterine factor infertility

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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200 participants in 3 patient groups, including a placebo group

N-acetyl cystien and clomiphen citrate

Active Comparator group

Description:

N-acetyl cystien and clomiphen citrate,in induction of ovulation in newly diagnosed PCOS,1-2gm schats of NAC PLUS 100 mg of cc in the therd day of the cycle till day 8,with monitoring of follicular growth usin ultrasonography.HCG is giving to trigger of ovulation fo follicular size 18mm or more.

Treatment:

Drug: NAC

Clomiphen citrate and placebo

Placebo Comparator group

Description:

CC plus placebo compared to cc and NAC in induction of ovulation in PCOS new cases.

Treatment:

Drug: NAC

N-acetyl cystien

No Intervention group

Description:

In addition to the CC, each patient was selected randomly to receive either NAC (Sedico, Cairo, ARE), in a dose of 1.2 g/d orally, or a placebo (sugar) of the same volume twice daily from day 3 until day 7