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

NCT ID: NCT01896492

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

N-acetyl cystien and clomiphen citrate

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.

Group Type: ACTIVE_COMPARATOR

NAC

Intervention Type: DRUG

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

Clomiphen citrate and placebo

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

Group Type: PLACEBO_COMPARATOR

NAC

Intervention Type: DRUG

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

N-acetyl cystien

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NAC

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

Intervention Type: DRUG

Other Intervention Names

N-acetyl cystien

Eligibility Criteria

Inclusion Criteria

• PCOS diagnosed by Rotterdam's criteria

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Woman's Health University Hospital, Egypt

OTHER

Sponsor Role: lead

Responsible Party

alaa eldeen mahmoud ismail

M D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaa M Ismail, M D

Role: PRINCIPAL_INVESTIGATOR

Woman's Health University Hospital, Egypt

Other Identifiers

ccpnacinovi

Identifier Type: -

Identifier Source: org_study_id